European Commission
Public Health

Public consultation on advanced therapy medicinal products

Guidelines on the details of the various categories of variations

Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures

EudraLex - Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form

Responses to the public consultation on the delegated act on post-authorisation efficacy studies

Revised rules on the distribution of medicinal products in the EU

EudraLex V27 - February 2013

Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an

Responses to the concept paper submitted for public consultation concerning the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public.

Responses to the concept paper submitted for public consultation concerning the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public.

Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products

Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council

Technical guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006

Revision of EU Commission guidelines on Good manufacturing Practice Medicinal Products

Today, the European Commission launches the public consultation of the following revised guidelines on good manufacturing practices:
Chapter 3: Premises and Equipment, Chapter 5: Production, Chapter 6: Quality Control, Chapter 8: Complaints, Quality Defects and Product Recalls.

Comments and suggestions are invited by 18 July 2013 and should be sent by email to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu

Responses to the public consultation : guidelines on the details of the various categories of variations

Outcome of the public consultation on the review of Regulation (EC) 1234/2008 article 4: variations guidelines

Public consultation on advanced therapy medicinal products

Stakeholders are invited to provide their views on the application of the Advanced Therapy Regulation at SANCO-ADVANCEDTHERAPY-REPORT@ec.europa.eu.  The consultation will be open until 31 March 2013.

Responses to the public consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency

Pharmacovigilance - Public consultation on post-authorisation efficacy studies

Commission facilitates importation of pharmaceutical active substances from Switzerland

Pharmacovigilance - Public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring

Quality of medicines and Good Manufacturing Practices

Importation of active substances for medicinal products for human use – Version 2.0 of the Questions and Answers document

Concept paper for public consultation on the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public

Update of application form for renewal of marketing authorisation (human and veterinary)

Medicines for children - Public consultation on the experience acquired with the paediatric regulation

Publication of chapter 1, chapter 7 and Annex 2 of the detailed guidelines of the good manufacturing practices

Public consultation on the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products

Concept paper for public consultation on the delegated act on the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced in the Union but not intended to be placed on the market.

Application of Articles 28(3), 36 and 37 of Regulation 1901/2006

New rules on importing active pharmaceutical ingredients into the EU – information leaflet

Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012

Commission adopts Proposal for a 'Clinical Trials Regulation'

The Commission has adopted, on 17 July 2012, a Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
This proposal, once adopted by the EU-legislator, is going to replace the 'Clinical Trials Directive' of 2001.

Importation of active substances - Template for the written confirmation, "Questions and Answers" document

Commission Call for Expression of Interest for the position of Member for the Committee for Advanced Therapies ('CAT') and the Pharmacovigilance Risk Assessment Committee ('PRAC')

Adoption and Publication of Commission Implementing Regulation on pharmacovigilance activities

Public Consultation Paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency

Public Consultation Paper on the review of the Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.

Responses to the public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use

Draft template for the written confirmation for active substances imported into the European Union for medicinal products for human use

Public consultation

Update of EudraLex Volume 2B - Presentation and content of the dossier

The European Medicines Agency announced today of the possibility to submit initial marketing authorisation applications for human medicines, variations and renewal applications for human and veterinary medicines using electronic application forms.
These forms, resulting from the collaboration of the EMA, the European Commission services and the National Competent Authorities, can be used for the centralised procedure, mutual recognition or decentralised procedures.

Commission Implementing Decisions amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.

The following new entries are included in the list of herbal substances, preparations and combinations:

• ‘Hamamelis virginiana L.’
• ‘Thymus vulgaris L' and 'Thymus zygis Loefl. ex L’
• 'Vitis vinifera L'.

Information to patients and Pharmacovigilance - New developments

On 10 February 2012, the Commission adopted:

• An amended Commission proposal for a Directive as regards information to the general public on medicinal products subject to medical prescription
• An amended Commission proposal for a Regulation as regards information to the general public on medicinal products subject to medical prescription
• A Commission proposal for a Directive as regards Pharmacovigilance
• A Commission proposal for a Regulation as regards Pharmacovigilance

Outcome of the public consultation on the review of Regulation (EC) 1234/2008

Responses to the Public consultation on the concept paper on implementing measures for the performance of pharmacovigilance activities

Responses to the public consultation on the "Revised Commission guidelines on Good Distribution Practice of Medicinal Products for human use"

Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use - concept paper submitted for public consultation

Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paer is being released for public consultation with a view to preparing the delegated act on principles and guidelines of good manufacturing practice for active substances in medicinal products for human use.

Implementing act on the requirements for the assessment of the regulatory framework applicable to the manufacturing of active substances of medicinal products – Public consultation

Directive 2011/62/EU introduces EU-wide rules for the importation of active substances: According to Article 46b(2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union. The requirement of a written confirmation is waived for third countries listed by the Commission in accordance with Article 111b of Directive 2001/83/EC. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. This concept paper is being rolled out for public consultation with a view to preparing this implementing act.

The European Commission adopts revised proposals setting out clearer rules on information on prescription-only medicines

The revised proposals amend the original Commission proposals of 2008 and take into account the European Parliament's amendments to the original proposals for legislation on information to patients.
The revised proposals sets out a clear framework whereby companies with marketing authorisation for a product may – and to some extent must – provide good quality and objective information on their prescription-only medicines to the general public. As a result, the proposals should lead to better empowered patients, more rational use of medicines, whilst, at the same time, maintaining the ban on advertising prescription-only medicines. It also seeks to further strengthen the current system for monitoring the safety of medicines, known as pharmacovigilance.
The revised proposals will now be debated by both the European Parliament and the Council of Ministers.

"Handling of duplicate marketing authorisations applications" - Update

The document "Handling of duplicate marketing authorisations applications" has been updated. A new section regarding the classification of the scope of Article 82(1) of  Regulation 726/2004 has been included. Prospective applicants are invited to consult the note prior to the submission of applications under Article 82(1)

Commission Call for Expression of Interest for the position of Member of the Management Board of the European Medicines Agency ('EMA') and for the position of Member of the following scientific committees of EMA: Committee for Advanced Therapies ('CAT'), Committee for Orphan Medicinal Products ('COMP') and the Pharmacovigilance Risk Assessment Committee ('PRAC')

With this call for expression of interest, the Commission wishes to invite all interested candidates to submit applications. Deadline 1 December 2011.

Public Consultation Paper on the review of Regulation (EC) 1234/2008 to the handling of variations to purely national marketing authorisations.

Public consultation on a concept paper on implementing measures for the performance of pharmacovigilance activities

In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation (cf. Regulation (EU) No 1235/2010 and Directive 2010/84/EU) the Commission shall adopt several implementing measures. Those measures supplement essential details of the new pharmacovigilance system with the more technical details that have to be observed by marketing authorisation holders, national competent authorities and the European Medicines Agency in the daily practice of applying the new provisions.

Public consultation of the revised Commission guidelines on Good Distribution Practice of Medicinal Products for Human Use

Today, DG SANCO launches a public consultation on the revised guidelines for good distribution practices. The content of the Guidelines on Good Distribution Practice published in 1994 is no longer adequate. It needs to be reviewed to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it needs to consider the new requirements for wholesale distributors and brokers established by the new Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

Responses to the public consultation on the concept paper on an “amendment of Commission Regulation (EC) 658/2007 concerning financial penalties for infringements committed by marketing authorisation holders of centrally authorised products”

Responses to the Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC.

EudraLex - Volume 10 Clinical trials guidelines

Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)

Video : EU Fights Fake Medicines

Video on the risks of fake medicines and on the wide range of actions taken by the EU to ensure the highest possible level of citizens' health.

Press release: EU adopts ambitious measures to fight against falsified medicines

EU/SFDA Pharmaceuticals Workshop - 19/20 May 2011

"Increased cooperation in Clinical Trials and Quality Control - A way forward to foster innovation, competitiveness and trade"

Medicines for children

The Paediatric Regulation (Regulation (EC) No 1901/2006) provides incentives and rewards to companies that have undertaken research into, and the development and authorisation of pharmaceuticals for children. The Commission is obligated to report on companies and products that have benefited from those rewards and incentives as well as on companies that have failed to comply with any of the obligations in the Regulation (Article 50(1) of the Regulation).
In this regard the European Medicines Agency has compiled a report covering the year 2010.

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines. Publication of the revised Annex 14 of the GMP guide as regards the manufacture of medicinal products Derived from Human Blood or Plasma

Today, the unit in charge of pharmaceuticals launches the publication of the revised Annex 14 of the GMP guide on the manufacture of medicinal products Derived from Human Blood or Plasma
The Annex has been revised in the light of Directive 2002/98/EC and relevant implementing directives setting standards of quality and safety for the collection and testing of human blood and blood components for all uses, including the manufacture of medicinal products. 
Deadline for coming into operation: 30 November 2011

Press release: Traditional herbal medicines: more safety for products put on EU market

From tomorrow, EU citizens can be reassured that the traditional herbal medicines they buy in the EU are safe and effective. The expiry of the 7 year transition period set out in the 2004 Herbal Directive (2004/24/EC) means that only medicinal products which have been registered or authorised can remain on the EU market after 1 May 2011.

Pharmaceuticals: today, the EU Register of Clinical Trials is launched Online

From today, all EU citizens will have access to information on the thousands of authorised pharmaceutical clinical trials that are underway in the EU. The aim of this official public register is to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials. Every year approximately 4000 clinical trials are authorised in the EU. Since most of them last 2 to 3 years, this means that around 10 000 trials are ongoing at any given time.

EudraLex - Volume 10 Clinical trials guidelines : updates

Guidance documents applying to clinical trials  - Questions & Answers Document, Version 8.0 and Guidance on Investigational Medicinal Products (IMPs) and 'non investigational medicinal products' (NIMPs), rev.1 (March 2011)

Public consultation on a concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC.

The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines : Publication of a revised introduction and the Site Master File

Publication of the new pharmacovigilance legislation in the Official Journal

Following adoption by the Council and the European Parliament, the new legislation on pharmacovigilance was published on 31 December 2010 in the Official Journal of the EU. The new legislation, a Regulation and a Directive, will become applicable in July 2012.

Clinical trials - Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissions

Publication of submissions

Commission is looking for health professionals and patient representatives for the Paediatric Committee

The Paediatric Regulation (Regulation (EC) No 1901/2006) establishes a scientific committee, the Paediatric Committee, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations. This committee shall include representatives of the civil society, which represent patient associations and health professionals.Those members are appointed by the Commission for a renewable period of three years on the basis of a public call for expression of interest.Today the Commission publishes such call and invites health professionals and patient associations to put forward candidatures, until 6 September 2010 at the latest, for a new mandate starting in 2011.
Update 10/09/2010: The Commission decided to prolong the deadline for submitting applications until 6 October 2010. Furthermore it is clarified that the proposed member and the proposed alternate do not have to represent necessarily the same associat

Clinical trials - Public consultation document – draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (‘CT‑3’)

Report on rewards and incentives under the Paediatric Regulation

The Paediatric Regulation (Regulation (EC) No 1901/2006) provides incentives and rewards to companies that have undertaken research into, and the development and authorisation of pharmaceuticals for children. The Commission is obligated to report on companies and products that have benefited from those rewards and incentives as well as on companies that have failed to comply with any of the obligations in the Regulation (Article 50(1) of the Regulation).

In this regard the European Medicines Agency has compiled a report, which covers the first three years of the Paediatric Regulation from its entry into force to 2009.

Clinical trials : Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissions

- Dossier requirements for non-investigational medicinal products; and
- List of fields for result-related information to be submitted to the EudraCT clinical trials database, and to be made public.

More information is available here . 

Clinical trials: Several documents have been published

- Update of substantial amendment notification form and end of trial notification form;
- Revised version of the 'Questions and Answers' guidance document.

List of herbals use in traditional herbal medicines

Commission decision of 25 March 2010 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products Commission Decision of 25 March 2010 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 26 March 2010. This decision includes ‘Mentha x piperita L.’ in the list of herbal substances.

Public consultation on Annex 2 of the GMP laying down the guidelines for the manufacture of biological medicinal substances and products for human use

Today, the unit in charge of pharmaceuticals launches a public consultation on Annex 2 of the good manufacturing practices laying down the guidelines for the manufacture of biological medicinal substances and products for human use.Annex 2 is proposed to be revised as a consequence of the restructuring of the GMP guide, the increased breadth of biological products to include several new product types such as transgenic derived products and the Advanced Therapy Medicinal Products, (ATMPs) together with associated new legislation. Significant changes have also been made as a result of the comments received from the first consultation.

Comments and suggestions are invited by 15 July 2010 and should be sent by email to: adm-gmdp@ema.europa.eu and ENTR-GMP@ec.europa.eu

Final report on Evaluation of the European Medicines Agency

An evaluation of the European Medicines Agency has been required by Regulation (EC) No 726/2004*, the Implementing Measures of the Financial Regulation and by the European Parliament.
The evaluation of the European Medicines Agency was conducted by Ernst & Young between January and December 2009 and a report was finalised subsequently.
On the basis of the assessment of the effectiveness and efficiency of the system, the evaluation addresses the contribution of the Agency to the protection of public and animal health, its contribution to the achievement of an operating internal market and the added value of the whole system for the stakeholders.
The evaluation report is hereby made public.

* Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Responses to the Public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"

Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products.

The Commission “Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products” Following Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products was adopted by the Commission on 21 December 2009 and shall be published in the Official Journal before the end of the year. The guideline applies from 1 January 2010.