In order to protect public health within the European Union (EU), imports of medicinal products are subject to the following requirements:

1. Importing authorisation
2. Marketing authorisation
3. Labelling and packaging provisions
4. Control of each batch
5. Pharmacovigilance system

Product scope

These requirements apply to medicinal products for human use, with the following exceptions:

• radionuclides in the form of sealed sources;
• whole blood, plasma or blood cells of human origin;
• medicinal products intended for research and development trials.

1. Importing authorisation

Importers of medicinal products into the EU must obtain an authorisation which is granted by the competent authority of the importing Member State provided that the applicant:

• specifies the medicinal products which are to be imported as well as the place where they are to be manufactured and/or controlled;
• has at his disposal suitable and sufficient premises, technical equipment and control facilities as regards both control and storage of these products;
• has at his disposal the services of at least one qualified person in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.

2. Marketing authorisation and register of medicinal products

Medicinal products may only be placed on the EU market when a marketing authorisation has been issued by the competent authorities of a Member State or by the European Medicines Agency.

Only applicants established in the EU may be granted a marketing authorisation.

The marketing authorisation holder is the person responsible for placing the medicinal product on the market.

Procedures for marketing authorisation:

A. EU centralised procedure

The competent authority for issuing marketing authorisations under this procedure is the EMA.

The EU centralised procedure is mandatory for medicinal products appearing in Annex I to Regulation (EC) 726/2004 (CELEX 32004R0726) unless otherwise indicated. For other medicinal products, such as those containing a new active substance which, on 20 May 2004, was not authorised in the Union, or those which may constitute a significant innovation, the applicant can choose whether to follow this procedure or the mutual recognition procedure explained below.

The application dossier must be submitted to the Agency and consists of administrative information and the necessary scientific documentation to demonstrate the quality, safety and efficacy of the medicinal product (results of physico-chemical, biological or microbiological tests, toxicological and pharmacological tests and clinical trials).

The label, the package leaflet and the container also become part of the marketing authorisation, therefore they need to be approved.

Marketing authorisations granted following this procedure are valid throughout the EU and shall be recorded in the European Register for medicinal products.

B. National procedure and mutual recognition of authorisations

For those medicinal products that are not subject to the EU centralised procedure, an application dossier must be submitted to the competent authorities of one or several Member States.

The national procedure is used to authorise medicinal products for local use in individual Member States.

Where national authorisations are requested in more than one Member State in a mutual recognition procedure, the application is to be submitted in one of the Member States (reference Member State) and once the marketing authorisation has been granted, the applicant submits identical application dossiers in other concerned Member States, requesting them to mutually recognise the marketing authorisation already granted.

The concerned Member States recognise it unless there are serious objections regarding a potential risk to public health. In such a case, arbitration by the European Medicines Agency can be requested.

The competent authorities of the Member States may grant a marketing authorisation for a generic form of a reference medicinal product already authorised by the EU.

C. Simplified procedures for homeopathic and herbal medicinal products

For homeopathic medicinal products a simplified procedure established by the importing Member State may be applied under certain conditions laid down in Directive 2001/83/EC (CELEX 32001L0083).

For herbal medicinal products, which fulfil certain requisites, a 'traditional-use' simplified registration procedure is established in the said Directive, as amended by 'The Traditional Herbal Medicinal Products Directive' (Directive 2004/24/EC (CELEX 32004L0024)). In order to obtain a 'traditional-use' registration, the applicant must submit an application to the competent authorities of the Member States.

Information on 'Herbal medicinal products' can be found on: Herbal medicinal products.

D. Conditional marketing authorisation

Certain medicinal products could obtain a marketing authorisation on the basis of less complete data than is normally the case and subject to specific obligations.

The product categories are:

• Medicinal products which aim at the treatment, prevention or medical diagnosis of seriously debilitating diseases or life-threatening diseases
• Medicinal products to be used in emergency situations
• Medicinal products designated as orphan medicinal products in accordance with art. 3 of (Regulation (EC) 141/2000 (CELEX 32000R0141))

The rules on the granting of conditional marketing authorisation are established in Regulation (EC) 507/2006 (CELEX 32006R0507).

The Union Register of medicinal products database

The pharmaceutical Unit of the European Commission Directorate-General for Health and Food Safety provides information on the product register status and other relevant details ( Product register status).

3. Labelling and packaging

Before granting a marketing authorisation for a medicinal product, the Member State's competent authority must check that the outer packaging, the immediate packaging and the package leaflet comply with the following provisions.

A. Labelling

1. Outer packaging

The following particulars must appear on the outer packaging or, in its absence, on the immediate packaging:

• the name of the medicinal product, its strength and pharmaceutical form and, if appropriate, whether its intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, in its absence, the common name
• common names of the active ingredients expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight
• the pharmaceutical form and the contents by weight, by volume or by number or doses
• a list of excipients known to have an effect and included in the detailed guidance published pursuant to the Directive; in the case of injectable products, or of topical or eye preparations, all excipients must be stated
• the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose.
• a special warning that the medicinal product must be stored out of the reach and sight of children
• a special warning, if necessary
• expiry date (month/year)
• special storage precautions, if necessary
• specific precautions for disposal of unused medicinal products or waste derived from them and reference to any appropriate collection system in place;
• the name and address of the marketing authorisation holder, and where applicable, the name of his representative
• the number of marketing authorisation
• the manufacturer's batch number
• instructions for use of non-prescription medicinal products
• for medicinal products other than radiopharmaceuticals, safety features enabling authorised operators to dispense medicinal products to the public to verify the authenticity of the medicinal product and identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with

Medicinal products not subject to prescription shall not bear the above mentioned safety measures unless they have been listed where a risk or falsification has been identified.

2. Immediate packaging

Immediate packaging in the form of blister packs and placed in an outer packaging shall bear at least the following particulars: name of the medicinal product, name of the marketing authorisation holder, the expiry date and the batch number.

Small immediate packaging units shall display at least: the name of the medicinal product, the method and route of administration (if necessary), the expiry date, the batch number and the contents by weight, by volume or by unit.

These particulars shall be easily legible, clearly comprehensible and indelible. The name of the medicinal product must also be expressed in Braille format.

Member States may require that the labelling includes additional information, such as the price of the product or the reimbursement conditions of social security organisations.

B. Package leaflet

The package leaflet covers the summary of the product characteristics and must include, in the following order:

1. For the identification of the medicinal product:
   • the name of the medicinal product, its strength and pharmaceutical form and, if appropriate, whether its intended for babies, children or adults. The common name must be included where the product contains only one active substance and its name is an invented name
   • the pharmaco-therapeutic group or type of activity in terms easily understandable for the patient
2. The therapeutic indications
3. A list of contra-indications, precautions for use, interactions with other medicinal products or with other products (e.g. tobacco, alcohol, foodstuffs) and special warnings. Particular conditions for certain categories of users (e.g. children, pregnant or breastfeeding women) must be taken into account. The list must also mention possible effects on the ability to drive vehicles or to operate machinery and enumerate those excipients whose knowledge is important for the safe and effective use of the product
4. Instructions for proper use: dosage, method and frequency of administration, duration of the treatment, action to be taken in case of an overdose or when one or more doses have not been taken, possible risk of withdrawal effects and a recommendation to consult the doctor or the pharmacist for any clarification
5. A description of the possible adverse reactions and the action to be taken in such a case
6. A warning against using the product after the expiry date and against visible signs of deterioration, special storage information, the qualitative and quantitative composition, the pharmaceutical form and content, the name and address of the marketing authorisation holder and of the manufacturer
7. A list of names authorised in each Member State
8. The date on which the package leaflet was last revised
9. Products subject to additional monitoring shall include the statement 'This medicinal product is subject to additional monitoring' preceded the black symbol included in the Annex to Regulation (EU) 198/2013 (CELEX 32013R0198) and followed by an appropriate standardised explanatory sentence

In order to clarify this information, the outer packaging and the package leaflet may include symbols or pictograms and other information which is useful for the patient. Indeed, a standardised text shall be included expressly asking patients to communicate any suspected adverse reaction specifying the different ways of reporting available.

The particulars must appear in an official language or official languages of the Member State where the product is marketed, as specified by that Member State for the purposes of this Directive.

Specific provisions apply to the packaging and container of medicinal products containing radionuclides, and to the labelling and package leaflets of homeopathic medicinal products.

C. Safety measures

Regulation (EU) 2016/161 (CELEX 32016R0161) applicable as of 9th February 2019, details the characteristics of the safety features and lays down a new verification system. This safety features consist of two elements placed on the packaging of a medicinal product:

1. a unique identifier, a unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed; and
2. a device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device).

The safety features should only be applied on the packaging of the following medicinal products for human use:

1. medicinal products subject to prescription which are not included in the list set out in Annex I to Regulation (EU) 2016/161 (CELEX 32016R0161)
2. medicinal products not subject to prescription included in the list set out in Annex II to Regulation (EU) 2016/161 (CELEX 32016R0161)
3. medicinal products to which Member States have extended the scope of the unique identifier or of the anti-tampering device in accordance with Article 54a(5) of Directive 2001/83/EC (CELEX 32001L0083).

4.Notification of arrival

According to Regulation (EU) 2024/2104 (CELEX 32024R2104), from 3 March 2025, Member States may request operators to notify the arrival of consignments of certain goods from third countries for which the Common Health Entry Document (CHED) is not required and to which articles 47 and 48 of Regulation (EU) 2017/625 (CELEX 32017R0625) do not apply.

The operator responsible for the consignment should notify the arrival of that consignment by completing and submitting the relevant data in the Trade Control and Expert System (TRACES) in the IMSOC, for transmission to the competent authorities at the border control posts of first arrival into the Union and for access to the data by customs authorities.

Using a standardised format, the notification of arrival should describe the consignment in sufficient detail to allow the competent authorities to immediately and completely identify the consignment, their destination and intended use, such as human consumption, feedstuff, sample, display exhibition item, food contact materials, plant protection products or other. In addition, the operator responsible for the consignment should certify that the information provided in the notification of arrival is true and complete.

5. Control of each batch

Each production batch of medicinal products imported from third countries has to undergo a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation. These analyses, tests or checks fall under the responsibility of the qualified person providing his services to the importing authorisation holder.

6. Pharmacovigilance system

Pharmacovigilance systems are established by the Member States in order to continuously monitor the safe use of medicinal products which have been placed on the market, collecting and evaluating information on misuse and abuse of these products, adverse reactions and side effects.

Marketing authorisation holders must implement a pharmacovigilance system equivalent to the system put in place by the Member States. Holders must:

• have at his disposal a qualified person responsible for pharmacovigilance
• maintain and make available on request a pharmacovigilance system master file
• implement a risk management system for each medicinal product
• monitor the results of risk reduction measures
• take measures to ensure the safe use of the medicinal product
• comply with obligations on the recording or reporting of suspected adverse reactions
• conduct post-authorisation safety studies
• submit periodic safety update reports

Holders of marketing authorisations for medicinal products must notify the Eudravigilance database of all suspected serious adverse reactions within 15 days of receiving such information and any non-serious suspected adverse reaction within 90 days.

The supervisory authority for pharmacovigilance shall be the competent authority of the Member State in which the pharmacovigilance system master file is located.

The Commission may impose financial penalties in the form of fines or periodic penalty payments on the holders of marketing authorisations if they fail to comply with any of the obligations laid down in Annex II to Regulation (EC) 726/2004 (CELEX 32004R0726) of the European Parliament and of the Council.

Legislation

• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L-136 30/04/2004) (CELEX 32004R0726)
• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L-311 28/11/2001) (CELEX 32001L0083)
• Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L-136 30/04/2004) (CELEX 32004L0024)
• Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L-18 22/01/2000) (CELEX 32000R0141)
• Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L-92 30/03/2006) (CELEX 32006R0507)
• Commission Implementing Regulation (EU) No 198/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring (OJ L-65 08/03/2013) (CELEX 32013R0198)
• Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L-32 09/02/2016) (CELEX 32016R0161)
• Commission Delegated Regulation (EU) 2024/2104 of 27 June 2024 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union (OJ L 2024/2104 25/09/2024) (CELEX 32024R2104)
• Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L-95 07/04/2017) (CELEX 32017R0625)
• Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L-324 10/12/2007) (CELEX 32007R1394)
• Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L-328 06/08/2008) (CELEX 32008D0911)
• Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L-159 20/06/2012) (CELEX 32012R0520)
• Commission Implementing Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required (OJ L-107 10/04/2014) (CELEX 32014R0357)
• Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L-238 16/09/2017) (CELEX 32017L1572)
• Commission Notice - Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2021/C 27/08 (OJ C-27 25/01/2021) (CELEX 52021XC0125(01))
• Commission Notice - Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the United Kingdom other than Northern Ireland 2021/C 524/02 2021/C 27/08 (OJ C-524 29/12/2021) (CELEX 52021XC1229(01))
• Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC (OJ L-157 20/06/2023) (CELEX 32023R1182)
• Commission notice 2022/C 440/02. Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another (OJ C-440 21/11/2022) (CELEX 52022XC1121(01))

Other information sources

• EMA: https://www.ema.europa.eu/en
• Herbal medicinal products: https://ec.europa.eu/health/human-use/herbal-medicines_en
• Product register status: https://ec.europa.eu/health/documents/community-register_en
• Medicinal products for human use: https://ec.europa.eu/health/medicinal-products_en
• Guideline on the packaging information of medicinal products for human use authorised by the Union: https://health.ec.europa.eu/system/files/2023-09/2018_packaging_guidelines_en_1.pdf

Imports of veterinary medicinal products into the European Union (EU), are subject to the following requirements established by Regulation (EU) 2019/6 (CELEX 32019R0006):

1. Importing authorisation
2. Marketing authorisation
3. Labelling and packaging provisions
4. Control of each batch
5. Pharmacovigilance system

Regulation (EU) 2019/6 (CELEX 32019R0006) repeals with effect from 28 January 2022 Directive 2001/82/EC (CELEX 32001L0082). Veterinary medicinal products placed on the market in accordance with Directive 2001/82/EC (CELEX 32001L0082) or Regulation (EC) 726/2004 (CELEX 32004R0726) may continue to be made available until 29 January 2027, even if they are not in compliance with this Regulation.

Product scope

These requirements apply to veterinary medicinal products prepared industrially or by a method involving an industrial process and intended to be placed on the market, with the following exceptions:

• Veterinary medicinal products containing autologous or allogeneic cells or tissues that have not been subjected to an industrial process
• Veterinary medicinal products based on radio-active isotopes
• Feed additives falling under Regulation (EC) 1831/2003 (CELEX 32003R1831)
• Veterinary medicinal products intended for research and development
• Medicated feed and intermediate products falling under Regulation (EU) 2019/4 (CELEX 32019R0004)

1. Importing authorisation

Importers of veterinary medicinal products into the EU must obtain an authorisation which is granted by the competent authority of the importing Member State provided that the applicant complies with the obligations set out in article 93 of Regulation (EU) 2019/6 (CELEX 32019R0006) .

The application for the autorisation shall contain at least the following information:

• veterinary medicinal products which are to be imported;
• name or company name and permanent address or registered place of business of the applicant;
• pharmaceutical forms which are to be imported;
• details about the manufacturing site where the veterinary medicinal products are to be imported;
• a statement to the effect that the applicant fulfils the requirements laid down in article 93 on the obligations of the holder of a manufacturing autorisation and article 97 which provides that the holder of a manufacturing authorisation shall have permanently at its disposal the services of at least one qualified person who fulfils the conditions and is responsible for carrying out the duties laid down in this article.

Manufacturing authorisations shall be valid throughout the Union.

2. Marketing authorisation and register of veterinary medicinal products

Veterinary medicinal products may only be placed on the EU market when a marketing authorisation has been issued by the competent authorities of a Member State or by the European Medicines Agency.

Only applicants established in the EU may be granted a marketing authorisation.This requirement shall also apply to marketing authorisation holders.

The marketing authorisation holder is the person responsible for placing the veterinary medicinal product on the market. The designation of a representative shall not exempt him of his legal responsibility.

A marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time.

An application for a marketing authorisation shall contain the following:

• the information set out in Annex I
• technical documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in accordance with the requirements set out in Annex II
• a summary of the pharmacovigilance system master file

Where the application is submitted in accordance with the national procedure, the applicant shall, in addition to the information, technical documentation and summary, submit a declaration stating that he or she has not submitted an application for a marketing authorisation for the same veterinary medicinal product in another Member State or in the Union and, if applicable, that no such marketing authorisation has been granted in another Member State or in the Union.

Where the application concerns an antimicrobial veterinary medicinal product, the following shall be submitted in addition to the information, technical documentation and summary:

• documentation on the direct or indirect risks to public or animal health or to the environment of use of the antimicrobial veterinary medicinal product in animals;
• information about risk mitigation measures to limit antimicrobial resistance development related to the use of the veterinary medicinal product.

The antimicrobials and group of antimicrobials listed in Regulation (EU) 2022/1255 (CELEX 32022R1255) cannot be used in veterinary medicinal products. Thus, marketing authorisation applications for veterinary medicinal products containing any of these antimicrobial elements will be refused. This regulation also prohibits the use in animals of medicinal products for human use that contain any of the antimicrobials or groups of antimicrobials listed.

Where the application concerns a veterinary medicinal product intended for food-producing animals and containing pharmacologically active substances that are not allowed in accordance with Regulation (EC) 470/2009 (CELEX 32009R0470) and with any acts adopted on the basis thereof for the animal species concerned, a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the Agency in accordance with that Regulation shall be submitted in addition to the information, technical documentation and summary.

This provision will not apply to veterinary medicinal products intended for animals of the equine species that have been declared as not being intended for slaughter for human consumption.

Where the application concerns a veterinary medicinal product containing or consisting of genetically modified organisms the application shall, in addition to the information, technical documentation and, be accompanied by:

• a copy of the written consent of the competent authorities to the deliberate release into the environment of the genetically modified organisms for research and development purposes, as provided for in Part B of Directive 2001/18/EC (CELEX 32001L0018);
• the complete technical file supplying the information required under Annex III and Annex IV to Directive 2001/18/EC (CELEX 32001L0018);
• the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC (CELEX 32001L0018); and
• the results of any investigations performed for the purposes of research or development.

Procedures for marketing authorisation:

A. EU centralised procedure

The competent authority for issuing marketing authorisations under this procedure is the EMA.

The EU centralised procedure is mandatory for he following veterinary medicinal products:

• veterinary medicinal products developed by means of one of the following biotechnological processes:
  • recombinant DNA technology
  • controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells
  • hybridoma and monoclonal antibody methods
• veterinary medicinal products intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals;
• veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the Union at the date of the submission of the application
• biological veterinary medicinal products which contain or consist of engineered allogeneic tissues or cells (not applicable to not apply to veterinary medicinal products consisting exclusively of blood components);
• novel therapy veterinary medicinal products (not applicable to not apply to veterinary medicinal products consisting exclusively of blood components).

For other veterinary medicinal products, a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the Union.

The application dossier must be submitted to the Agency and shall state a single name for the veterinary medicinal product to be used throughout the Union.

The summary of product characteristics, the text of the labelling and the package leaflet also become part of the marketing authorisation, therefore they need to be approved.

Marketing authorisations granted following this procedure are valid throughout the EU and shall be recorded in the Union database on veterinary medicinal products (Union product database).

B. National procedure

For those veterinary medicinal products that are not subject to the EU centralised procedure, an application dossier must be submitted to the competent authoritiy in the Member State for which the authorisation is applied.

The national procedure is used to authorise veterinary medicinal products for local use in individual Member States.

A national marketing authorisation shall be valid only in the Member State of the competent authority which granted it.

National marketing authorisations shall not be granted in respect of veterinary medicinal products for which a national marketing authorisation has been granted, or for which an application for a national marketing authorisation is pending in another Member State at the time of the application.

C. Decentralised procedure

Decentralised marketing authorisations shall be granted by the competent authorities in the Member States in which the applicant seeks to obtain a marketing autorisation (Member States concerned). Such decentralised marketing authorisations shall be valid in those Member States.

It shall be submitted to the competent authority in the Member State chosen by the applicant to prepare an assessment report (reference Member State) and to the competent authorities in the other Member States concerned. The application shall list the Member States concerned.

Decentralised marketing authorisations shall not be granted in respect of veterinary medicinal products for which a national marketing authorisation has been granted, or for which an application for a marketing authorisation is pending at the time of the application for a decentralised marketing authorisation, or for those veterinary medicinal products that are subject to the EU centralised procedure.

D. Mutual recognition of national marketing authorisations

A national marketing authorisation for a veterinary medicinal product shall be recognised in other Member States in accordance with the following procedure.

An application for mutual recognition of a national marketing authorisation shall be submitted to the competent authority in the Member State that granted the national marketing authorisation (reference Member State) and to the competent authorities in the Member States where the applicant seeks to obtain a marketing authorisation (Member States concerned).

The application for mutual recognition shall list the Member States concerned.

A minimum of six months shall elapse between the decision granting the national marketing authorisation and the submission of the application for mutual recognition of that national marketing autorisation.

E. Subsequent recognition in the mutual recognition and decentralised marketing authorisation procedures

After completion of a decentralised procedure or a mutual recognition procedure granting a marketing authorisation, the marketing authorisation holder may submit an application for a marketing authorisation for the veterinary medicinal product to the competent authorities in additional Member States concerned and to the competent authority in the reference Member State, as applicable. In addition, the application shall include the following:

• a list of all decisions granting, suspending or revoking marketing authorisations which concern the veterinary medicinal product;
• information on the variations introduced since the grant of the marketing authorisation by decentralised procedure;
• a summary report on pharmacovigilance data.

F. Simplified procedure for homeopathic veterinary medicinal products

A simplified registration procedure is enabled for homeopathics without therapeutic indication that fullfill the following conditions:

• it is administered by a route described in the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially in Member States;
• it has a sufficient degree of dilution to guarantee its safety, and shall not contain more than one part per 10 000 of the mother tincture;
• it has no therapeutic indication appearing on its labelling or in any information relating thereto.

Special provisions for veterinary medicinal products intended for animals of food producing species and pets

A marketing authorisation for a veterinary medicinal product intended for one or more food-producing animal species may only be granted if the pharmacologically active substance is allowed in accordance with Regulation (EC) 470/2009 (CELEX 32009R0470) which establishes residue limits of pharmacologically active substances in foodstuffs of animal origin, as well as in any acts adopted on the basis thereof for the animal species concerned.

In the case of veterinary medicinal products intended for animals which are exclusively kept as pets: aquarium or pond animals, ornamental fish, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits, Member States may allow exemptions, provided that such veterinary medicinal products are not subject to a veterinary prescription and that all necessary measures are in place in the Member State to prevent unauthorised use of those veterinary medicinal products for other animals.

Specific requirements for generic, hybrid and combination veterinary medicinal products and for applications based on informed consent and bibliographic data

For these kind of products, additional or fewer data to be submitted with the application for autorisation may be required, provided certain conditions are fulfilled.

The Union database on veterinary medicinal products (Union product database)

Regulation (EU) 2021/16 (CELEX 32021R0016) lays down the necessary measures and practical arrangements for the Union product database. It is aimed at enhancing the single market by providing information on veterinary medicinal products available in Member States and allowing health professionals to obtain information on veterinary medicinal products which might be considered for elaboration of potential treatment alternatives where no suitable veterinary medicinal product is authorised in their Member State.

The marketing authorisation holders shall record in the product database the dates when its authorised veterinary medicinal products are placed on the market, information on the availability for each veterinary medicinal product in each relevant Member State and, as applicable, the dates of any suspension or revocation of the marketing authorisations concerned.

3. Labelling and packaging

Information concerning the veterinary medicinal product, and in particular the labelling and package leaflet, must be in conformity with the summary of product characteristics approved when the marketing authorisation was granted.

The language or languages of the information on the labelling and on the package leaflet shall, unless the Member State determines otherwise, be an official language or languages of the Member State in which the veterinary medicinal product is marketed. Veterinary medicinal products may be labelled in several languages.

A. Labelling

The immediate packaging shall bear the following information in easily legible and clearly comprehensible characters, or in abbreviations or pictograms common throughout the Union:

• the name of the veterinary medicinal product, followed by its strength and pharmaceutical form
• a statement of the active substances expressed qualitatively and quantitatively per unit or according to the form of administration for a particular volume or weight, using their common names
• the batch number, preceded by the word Lot
• the name or company name or logo name of the marketing authorisation holder
• the target species
• the expiry date, in the format: mm/yyyy, preceded by the abbreviation Exp.
• special storage precautions, if any
• route of administration
• if applicable, the withdrawal period, even if such period is zero.

Additionally, the outer packaging shall contain the following information:

• the contents by weight, volume or number of immediate packaging units of the veterinary medicinal product
• a warning that the veterinary medicinal product must be kept out of the sight and reach of children
• a warning that the veterinary medicinal product is for animal treatment only
• without prejudice to Article 14(4), a recommendation to read the package leaflet
• in the case of homeopathic veterinary medicinal products, the statement homeopathic veterinary medicinal product
• in the case of veterinary medicinal products not subject to a veterinary prescription, the indication or indications
• the marketing authorisation number.

Where there is no outer packaging, all the information to be included on it, shall appear on the immediate packaging.

A Member State may decide that, on the immediate packaging and on the outer packaging of a veterinary medicinal product made available in its territory, an identification code shall be added to the information required. Such a code may be used to replace the marketing authorisation number.

Regulation (EU) 2024/875 (CELEX 32024R0875) sets out the Abbreviations and Pictograms to be used to replace the written information required on the labelling of immediate packaging and on the outer packaging of veterinary medicinal products. No other abbreviations and pictograms than those listed in the Annexes to Regulation (EU) 2024/875 (CELEX 32024R0875) shall be used to replace that written information. The abbreviations and pictograms shall only be used to replace the corresponding text as set out in the Annexes. They shall not be used to replace any other information concerning the veterinary medicinal product. They must be explained in full text in the package leaflet of the veterinary medicinal product concerned.

As regards Immediate packaging units which are too small to contain in a readable form the above mentioned information shall contain the following information:

• the name of veterinary medicinal product
• the quantitative particulars of the active substances
• the batch number, preceded by the word Lot
• the expiry date, in the format: mm/yyyy, preceded by the abbreviation Exp..

In accordance with Regulation (EU) 2024/878 (CELEX 32024R0878), the following types of immediate packaging shall be considered to be small immediate packaging units:

• blisters or strips
• ampoules and small single-dose containers other than ampoules
• a container or any other form of packaging that is in direct contact with the veterinary medicinal product and has a nominal volume of up to and including 50 ml

Competent authorities of Member States may consider multilingual immediate packaging units not exceeding 100 ml to qualify as small immediate packaging units when they are too small or have a shape or configuration that makes it impossible to accommodate in readable form all the labelling information as set out in ('32019R0006'). For those cases, a derogation to the 50 ml threshold should be provided for. To ensure that the user is correctly informed on the properties of the product, this derogation should only apply to veterinary medicinal products subject to veterinary prescription.

Member States may, within their territory, and on request of the applicant, allow to include on the immediate packaging or outer packaging of a veterinary medicinal product additional useful information which is compatible with the summary of the product characteristics and which is not an advertisement for a veterinary medicinal product.

B. Package leaflet

It is mandatory to include a package leaflet unless all the information required can be provided on the packaging.

Leaflets must be written and designed to be readable, clear and understandable, in terms that are comprehensible to the general public and they must include at least the following information:

• the name or company name and permanent address or registered place of business of the marketing authorisation holder and of the manufacturer and, where applicable, of the representative of the marketing authorisation holder
• the name of the veterinary medicinal product, followed by its strength and pharmaceutical form
• qualitative and quantitative composition of the active substance or substances
• the target species, the dosage for each species, the method and route of administration and, if necessary, advice on correct administration
• the indications for use
• the contra-indications and adverse events
• if applicable, the withdrawal period, even if such period is zero
• special storage precautions, if any
• information essential for safety or health protection, including any special precautions relating to use and any other warnings
• information on the collection systems applicable to the veterinary medicinal product concerned
• the marketing authorisation number
• contact details of the marketing authorisation holder or its representative, as appropriate, for the reporting of suspected adverse events
• classification of the veterinary medicinal product.

The package leaflet may bear additional information concerning distribution, possession or any necessary precaution in conformity with the marketing authorisation, provided that the information is not promotional. That additional information shall appear in the package leaflet clearly separated from the information referred above.

Special provisions apply to registered homeopathic veterinary medicinal products.

4.Notification of arrival

According to Regulation (EU) 2024/2104 (CELEX 32024R2104), from 3 March 2025, Member States may request operators to notify the arrival of consignments of certain goods from third countries for which the Common Health Entry Document (CHED) is not required and to which articles 47 and 48 of Regulation (EU) 2017/625 (CELEX 32017R0625) do not apply.

The operator responsible for the consignment should notify the arrival of that consignment by completing and submitting the relevant data in the Trade Control and Expert System (TRACES) in the IMSOC, for transmission to the competent authorities at the border control posts of first arrival into the Union and for access to the data by customs authorities.

Using a standardised format, the notification of arrival should describe the consignment in sufficient detail to allow the competent authorities to immediately and completely identify the consignment, their destination and intended use, such as human consumption, feedstuff, sample, display exhibition item, food contact materials, plant protection products or other. In addition, the operator responsible for the consignment should certify that the information provided in the notification of arrival is true and complete.

5. Control of each batch

Each production batch of veterinary medicinal products imported from third countries has to undergo in the Union a full qualitative and quantitative analysis of at least all the active substances and all the other tests necessary to ensure the quality of the veterinary medicinal products in accordance with the requirements of the marketing autorisation and that the batch is in compliance with good manufacturing practice. These analyses, tests or checks fall under the responsibility of the qualified person providing his services to the importing authorisation holder.

6. Pharmacovigilance system

Pharmacovigilance systems are established in order to continuously monitor the safety and efficacy of authorised veterinary medicinal products which have been placed on the market, collecting and evaluating information on misuse and abuse of these products, adverse reactions and side effects.

Marketing authorisation holders should respect good pharmacovigilance practice by implementing a pharmacovigilance system, supported by a quality management system covering all pharmacovigilance activities, including a risk management system covering all procedures and processes necessary to optimise safe use of their veterinary medicinal products. The quality management system should be updated regularly and checked by audits at risk-based intervals, and should include provisions to identify corrective and preventive actions and manage and document corresponding changes to those actions.

The marketing authorisation holder's pharmacovigilance system shall meet the requirements laid down in Regulation (EU) 2021/1281 (CELEX 32021R1281).

In particular, holders must:

• operate, maintain and make available on request a pharmacovigilance system master file
• have at his disposal a qualified person responsible for pharmacovigilance
• comply with obligations on the collecting, recording and reporting of suspected adverse events for their veterinary medicinal products
• carry out post-marketing surveillance studies
• ensure that public announcements relating to information on pharmacovigilance concerns are presented objectively and are not misleading and to notify them to the Agency
• comply with good pharmacovigilance practice for veterinary medicinal products
• supply any new information which may entail a variation to the terms of the marketing autorisation
• continuously evaluate the benefit-risk balance of this veterinary medicinal product and, if necessary, take appropriate measures.

Marketing authorisation holders shall record in the pharmacovigilance database all suspected adverse events which were reported to them and that occurred within the Union or in a third country or that have been published in the scientific literature with regard to their authorised veterinary medicinal products, without delay and no later than within 30 days of receipt of the suspected adverse event report.

The Commission may impose financial penalties in the form of fines or periodic penalty payments on the holders of marketing authorisations if they fail to comply with any of the obligations laid down in Annex III.

Legislation

• Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L-4 07/01/2019) (CELEX 32019R0006)
• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L-136 30/04/2004) (CELEX 32004R0726)
• Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L-268 18/10/2003) (CELEX 32003R1831)
• Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L-4 07/01/2019) (CELEX 32019R0004)
• Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L-191 20/07/2022) (CELEX 32022R1255)
• Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L-152 16/06/2009) (CELEX 32009R0470)
• Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L-106 17/04/2001) (CELEX 32001L0018)
• Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database) (OJ L-7 11/01/2021) (CELEX 32021R0016)
• Commission Implementing Regulation (EU) 2024/875 of 21 March 2024 adopting a list of abbreviations and pictograms common throughout the Union to be used on the packaging of veterinary medicinal products for the purposes of Article 10(2) and Article 11(3) of Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 2024/875 22/03/2024) (CELEX 32024R0875)
• Commission Implementing Regulation (EU) 2024/878 of 21 March 2024 adopting uniform rules on the size of small immediate packaging units of veterinary medicinal products as referred to in Article 12 of Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 2024/878 22/03/2024) (CELEX 32024R0878)
• Commission Delegated Regulation (EU) 2024/2104 of 27 June 2024 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union (OJ L 2024/2104 25/09/2024) (CELEX 32024R2104)
• Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L-95 07/04/2017) (CELEX 32017R0625)
• Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products (OJ L-279 03/08/2021) (CELEX 32021R1281)
• Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L-7 11/01/2021) (CELEX 32021R0017)
• Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation (OJ L-123 09/04/2021) (CELEX 32021R0577)
• Commission Implementing Regulation (EU) 2021/963 of 10 June 2021 laying down rules for the application of Regulations (EU) 2016/429, (EU) 2016/1012 and (EU) 2019/6 of the European Parliament and of the Council with regard to the identification and registration of equine animals and establishing model identification documents for those animals (OJ L-213 16/06/2021) (CELEX 32021R0963)
• Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans (OJ L-353 06/10/2021) (CELEX 32021R1760)
• Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance (OJ L-387 03/11/2021) (CELEX 32021R1904)
• Regulation (EU) 2022/839 of the European Parliament and of the Council of 30 May 2022 laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 (OJ L-148 31/05/2022) (CELEX 32022R0839)
• Commission Notice - Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2021/C 27/08 (OJ C-27 25/01/2021) (CELEX 52021XC0125(01))
• Commission Notice - Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the United Kingdom other than Northern Ireland 2021/C 524/02 2021/C 27/08 (OJ C-524 29/12/2021) (CELEX 52021XC1229(01))

Other information sources

• EMA: https://www.ema.europa.eu/en
• Veterinary medicinal products: https://ec.europa.eu/food/animals/health/veterinary-medicines-and-medicated-feed_en
• Guideline on the packaging information of veterinary medicinal products authorised by the Community: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-6/c/v6c_packaging_veterinary_en.pdf

Active substances intended to be used as raw materials in the manufacture of medicinal products for human use and veterinary medicinal products can only be imported by registered authorised operators in the importing Member State. In order to be authorised, operators must meet at least the following requirements:

• specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;
• have at their disposal suitable and sufficient premises, technical equipment and control facilities as regards both control and storage of these products;
• have at their disposal the services of at least one qualified person in one of the following scientific disciplines: pharmacy, human medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.

Active substances for medicinal products for human use may only be imported provided they fulfill certain conditions:

• have been manufactured in accordance with standards of good manufacturing practice, in accordance with the principles and guidelines laid down in Regulation (EU) 1252/2014 (CELEX 32014R1252);
• are accompanied by a written confirmation from the competent authority of the exporting third country ensuring that the legislative provisions applicable to the manufacturing of active substances intended for export to the Union, as well as inspections of facilities and enforcement of the applicable provisions, provide for a level of protection of public health equivalent to that provided for by Union law.
  The written confirmation shall not be required if the exporting country is included in the list set out in Decision 2012/715/EU (CELEX 32012D0715) establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC (CELEX 32001L0083).

Active substances for veterinary medicinal products may only be imported provided they fulfill certain conditions:

• have been manufactured in accordance with standards of good manufacturing practice in accordance with the principles and guidelines laid down in Regulation (EU) 2021/1280 (CELEX 32021R1280);
• the importer is registered with the competent authority of the Member State in which is established. The registration form for registering the activity with the competent authority shall include at least the following information:
  • name or company name and permanent address or registered place of business;
  • the active substances which are to be imported, manufactured or distributed;
  • o particulars regarding the premises and the technical equipment.

The importer shall submit the registration form to the competent authority at least 60 days prior to the intended start of their activity.

Legislation

• Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (OJ L-337 25/11/2014) (CELEX 32014R1252)
• Commission Implementing Decision of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC (OJ L-325 23/11/2012) (CELEX 32012D0715)
• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L-311 28/11/2001) (CELEX 32001L0083)
• Commission Implementing Regulation (EU) 2021/1280 of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L-279 03/08/2021) (CELEX 32021R1280)
• Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L-4 07/01/2019) (CELEX 32019R0006)

Cosmetic products are subject to composition, packaging, labelling, and information requirements in order to be placed on the market in the European Union (EU). These requirements are enforced by means of establishing the liability of the manufacturer or importer for their products, requiring a notification of first importation and performing in-market surveillance controls.

Product scope

Regulation (EC) 1223/2009 (CELEX 32009R1223) provides a general description to cosmetic products. According to Article 2 of the Regulation, cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to:

• clean,
• perfume,
• change the appearance,
• protect,
• keep in good condition,
• correct body odours.

Substances or mixtures intended to be ingested, inhaled, injected or implanted into the human body are excluded from the scope of the Regulation.

Requirements

Only cosmetic products for which a person is designated within the EU as responsible person can be placed on the market. This person shall ensure compliance with the rules set out in the Regulation, in particular requirements relating to human health, safety and consumer information. For imported cosmetic products, each importer shall be the responsible person for the specific cosmetic product placed on the market. The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.

1. Composition

Cosmetic products containing certain substances are prohibited:

• substances listed in Annex II to the Regulation, in any case and under any conditions (nevertheless, the non-intended presence of traces of these substances, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, is allowed provided that such substances are technically unavoidable in good manufacturing practice and that the product does not cause damage to human health);
• substances listed in Annex III to the Regulation, not used in accordance with the restrictions laid down.

Colouring agents, preservatives and UV filters that are allowed to be used as ingredients for cosmetic products are respectively listed in Annex IV, Annex V and Annex VI to the Regulation.

The use of substances which are carcinogenic, mutagenic or toxic for reproduction (classified as CMR) is prohibited, apart from in exceptional cases.

The Regulation also prohibits the placing on the European Union market of products where the final formulation has been the subject of animal testing and products containing ingredients or combination of ingredients which have been the subject of animal testing. In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.

2. Notification of first importation

Before placing imported cosmetic products on the EU market, the responsible person must indicate to the Commission via the EU Cosmetic Products Notification Portal (CPNP) the following information:

• the category of cosmetic product and its name or names, enabling its specific identification;
• the name and address of the responsible person where the product information file is made readily accessible;
• the country of origin in the case of import;
• the Member State in which the cosmetic product is to be placed on the market;
• the contact details of a physical person to contact in the case of necessity;
• the presence of substances in the form of nanomaterials including their identification and the reasonably foreseeable exposure conditions;
• the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) 1272/2008 (CELEX 32008R1272);
• the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.

Cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market containing at least the following:

• identification including its chemical name and other descriptors,
• specification including size of particles, physical and chemical properties,
• an estimate of the quantity contained intended to be placed on the market per year,
• toxicological profile,
• safety data,
• reasonably foreseeable exposure conditions.

If the Commission has concerns regarding the safety of a nanomaterial, cosmetic products will be object of a full safety assessment at EU level.

3. Safety assessment

Prior to placing a cosmetic product on the market, the responsible person shall ensure that it has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I to the Regulation.

4. Information availability

The person responsible for placing imported cosmetic products on the market must keep the following information readily accessible at the address specified on the label and in a language accepted by its legislation:

• description of the cosmetic product;
• the cosmetic product safety report;
• method of manufacture and a statement on compliance with good manufacturing practice;
• proof of the effect claimed for the cosmetic product;
• data on any animal testing performed.

The responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product are easily accessible to the public by any appropriate means. The quantitative information regarding the composition of the cosmetic product required to be made publicly accessible shall be limited to hazardous substances in accordance with article 3 of Regulation (EC) 1272/2008 (CELEX 32008R1272).

5. Packaging and labelling

Cosmetic products can be marketed only if the cosmetic container and packaging bear the following information in indelible, easily legible and visible lettering:

• The name and the address of the responsible person. The country of origin shall be specified for imported cosmetic products.
• The nominal content at the time of packaging, given by weight or volume.
• The date of minimum durability preceded by the symbol shown in point 3 of Annex VII or the words best used before the end of. This is not mandatory for products with a minimum durability of more than 30 months, which must have an indication of the period of time after opening for which the product can be used without causing any harm to the consumer. This information shall be indicated by the symbol given in point 2 of Annex VII followed by the period.
• Particular precautions to be observed in use.
• The batch number of manufacture or the reference for identifying the goods. If the size of the product is too small this information may be indicated only on the packaging.
• The function of the product.
• A list of ingredients which may be indicated on the packaging alone and the heading to the ingredient list should be ingredients. The ingredients are to be expressed using the common ingredient names set out in a glossary to be compiled and updated by the Commission. To that end the Commission has adopted the glossary of common ingredient names by Decision (EU) 2022/677 (CELEX 32022D0677). Nanomaterials are to be indicated in the list of ingredients with the word nano in brackets following the name of the substance. Perfume and aromatic compositions should be listed as 'parfum' and 'aroma' respectively. However, the presence of substances, the mention of which is required under the column Other in Annex III to the Regulation, shall be indicated in the list in addition to the terms parfum or aroma.

Where it is impracticable, for reasons of size or shape, for the particulars referred to in points (d) and (g), to appear in the cosmetic container or packaging, they can be included in a leaflet, label, tape, tag or card enclosed or attached to the cosmetic product to which the consumer is referred either by abbreviated information or by the symbol given in point 1 of Annex VII.

Additionally Member States' legislation may require that the particulars provided for in points b, c, d, and f be expressed at least in their own national or official language(s).

Claims which may be used on cosmetics must meet the common criteria set out in the Annex to Regulation (EU) 655/2013 (CELEX 32013R0655).

Market surveillance

The responsible person will have an obligation to notify serious undesirable effects to competent authorities. The authorities will also collect information coming from users and health professionals and will be obliged to share the information with other EU Member States.

In-market controls, accomplished by the Member States' authorities, will ensure that only cosmetic products which conform to EU provisions are circulating on the market.

Legislation

• Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L-342 22/12/2009) (CELEX 32009R1223)
• Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging (CLP) of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) 1907/2006 (OJ L-353 31/12/2008) (CELEX 32008R1272)
• Commission Implementing Decision (EU) 2022/677 of 31 March 2022 laying down rules for the application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the glossary of common ingredient names for use in the labelling of cosmetic products (OJ L-127 29/04/2022) (CELEX 32022D0677)
• Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products (OJ L-190 11/07/2013) (CELEX 32013R0655)
• Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L-50 20/02/2004) (CELEX 32004L0010)
• Commission Implementing Decision 2013/674/EU of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L-315 26/11/2013) (CELEX 32013D0674)

Other information sources

• Cosmetics: https://ec.europa.eu/growth/sectors/cosmetics_en