Medicines for children: Consultation to gather stakeholders' experiences of the EU Paediatric Regulation opens today!
29 July 2016Public consultations on the concept of 'similar medicinal product' in the context of the orphan legislation
29 July 2016Responses to the public consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release testing
06 July 2016Study on the regulation of advanced therapies in selected jurisdictions
28 June 2016Targeted stakeholder consultation on the draft Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products
27 June 2016Draft Agenda now available for 5th Meeting of the Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) on 28 June 2016 (Brussels).
20 June 2016Updated Q&A (v.5) on safety feature now available.
16 June 2016Updated Q&A (v.7) on importation of active substances (APIs) now available.
01 June 2016Launch of four public consultations on recommendations related to clinical trials
10 March 2016Health-EU Newsletter - Falsified Medicines
07 March 2016Launch of ‘PRIME’ scheme to pave the way for promising medicines
26 February 2016Inventory of Union and Member State incentives to support research into, and the development and availability of, orphan medicinal products — state of play 2015
10 February 2016New safety features to protect EU consumers from falsified medicines
22 January 2016Regulatory Information 01/2016 - Variations - Article 57 database
18 November 2015Public consultation on a new notice on orphan medicinal products launched on 17/11/2015
01 October 2015Video recording - Conference on '50 Years of EU Pharma legislation: Achievements and future perspectives' (28 September 2015)
30 September 2015Deadline for submission prolonged until 18 October 2015 - Civil Society representatives: Call for expressions of interest for the EMA PRAC and EMA CAT Committees
25 September 2015Health-EU Newsletter - Pharmaceutical legislation
22 September 2015European Commission, European Medicines Agency and World Health Organization step up cooperation to better protect global public health
17 September 2015Live web streaming (10 AM - 4.30 PM, 28 September 2015) - Conference on '50 Years of EU Pharma legislation: Achievements and future perspectives' (Brussels)
27 July 2015Deadline for registration prolonged to 1st September - Conference on '50 Years of EU Pharma legislation: Achievements and future perspectives'
23 July 2015Civil Society representatives: Call for expressions of interest is open for the EMA PRAC and EMA CAT Committees
10 July 2015Civil Society representatives: Call for expression of interest is open for the EMA Management Board
30 June 2015New EU logo to help patients avoid online sellers of fake medicines
16 June 2015Registration open (deadline: 24 July 2015) - Conference on '50 Years of EU Pharma legislation: Achievements and future perspectives' (Brussels, 28 September 2015)
20 May 2015EudraBook V1 - Compendium of EU pharmaceutical law
EudraBook V1 - May 2015 - Compendium of EU pharmaceutical law
The main body of EU legislation on medicinal products for human use is now available in e-book format.
23 October 2014New version of Clinical trials
A complete revision of the chapter on clinical trials has been published on the website
02 October 2014Commission Call for Expressions of Interest for the position of member of the Committee for Orphan Medicinal Products (COMP) as representing patient organisations
This call for expressions of interest relates to the appointment by the Commission of members representing patient organisations at the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency.
30 September 2014Medicines for children - New Commission guideline on paediatric investigation plans
10 September 2014Veterinary medicinal products : Adoption of proposal by European Commission
On 10 September 2014 the European Commission adopted
proposals on veterinary medicinal products and medicated feed. With its
proposal on veterinary medicinal products, the Commission aims to tailor legislation
on veterinary medicinal products to the needs of the veterinary sector, without
jeopardising public and animal health, or a safe environment.
EudraLex V29 - September 2014
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine
The Eudralex V29 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf format and without protection. For a non-commercial use, Eudralex V29 may be duplicated, shared and the documents may be printed. 18 June 2014Medicines and the Environment - Study on the risks of environmental effects of medicinal products
The study on the risks of environmental effects of medicinal products has been financed by the Commission and carried out by an external contractor (BIO Intelligence Service). Its objectives are to characterise the scale of the environmental effects of medicinal products and to identify non-legislative and legislative causes and possible solutions across the entire EU legislative framework. It constitutes a starting point from which the different aspects need to be further validated by the European Commission based on the contributions from the European Medicines Agency, the European Environment Agency, Member States and stakeholders.
06 June 2014Medicines for Children : Annual report on benefits and infringements under the Paediatric Regulation
27 May 2014Clinical trials : New Regulation No 536/2014
The New Regulation No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was published in the Official Journal on 27 May 2014.
26 May 2014Notice to applicants, medicinal products for human use, volume 2A, chapter 3 Union referral procedure
The update of chapter 3 of volume 2A of the notice to applicants is published.
02 May 2014Medicines for Children - Responses to the public consultation on the Commission guideline on paediatric investigation plans
02 May 2014One-year report on human medicines pharmacovigilance tasks of the European Medicines Agency
16 April 2014Questions & Answers: Fees for Pharmacovigilance activities - Press release
01 April 2014Good Distribution Practice : A "Question and Answer" document (version 1.0 March 2014)
A "Question and Answer" document (version 1.0 March 2014) responds to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use."
01 April 2014Advanced therapies - Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products
The European Commission has adopted a Report on the application of the Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (“ATMP Regulation”). In the report, the Commission takes stock of the situation of advanced therapy medicinal products in the EU and analyses the impact of the Regulation on advanced therapies.
28 March 2014Revision of the Guideline on the format and content of applications for designation as orphan medicinal products
06 February 2014Public consultation on the revision of Annex 15: Qualification and Validation.
Today the European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.
20 December 2013Health Commissioner, Tonio Borg, welcomes agreement on the revision of EU rules on Clinical Trials
31 October 2013EC Report highlights the potential of Personalised Medicine
09 October 2013Public consultation on Commission guideline on paediatric investigation plans
01 October 2013Medicines undergoing additional monitoring: Video and leaflet to explain new symbol
Since 1 September, a black inverted triangle has started to appear in the product information of medicines that are being monitored particularly closely by regulatory authorities. With this measure, the European Commission aims to improve the safety of medicines and also to highlight to patients, the importance of reporting suspected side effects to the medicines they are taking.
05 September 2013Commission Call for Expression of Interest for the position of member for the Paediatric Committee ('PDCO')
17 July 2013Notice to applicants, update of Guideline on the packaging information of medicinal products for human use authorised by the Union.
The Notice to applicants, volume 2C Regulatory guidelines have been updated with the publication of the updated guideline on the packaging information of medicinal products for human use authorised by the EU.
Volume 2C : Human medicinal products - Regulatory Guidelines >>>
05 July 2013Public consultation on the revision of EU Commission guidelines on Good Manufacturing Practice for Medicinal Products
05 July 2013Public consultation on the 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
24 June 2013Medicines For Children - First Commission Report on the Paediatric Regulation
The Commission has published today a progress report on medicines for children covering the five years since the Paediatric Regulation first came into force. This preliminary snapshot points to improvements in the paediatric medicines landscape: better and safer research, more medicines for children on the EU market and more information for parents and health professionals.
31 May 2013Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form
The electronic version of the revised version of the application form is available (revision 10.1). The external link has been added on the website.
22 May 2013Public consultation on advanced therapy medicinal products
17 May 2013Guidelines 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
16 April 2013EudraLex - Notice to applicants, medicinal products for human use, volume 2B, module 1.2 administrative information application form
15 March 2013Responses to the public consultation on the delegated act on post-authorisation efficacy studies
08 March 2013Revised rules on the distribution of medicinal products in the EU
22 February 2013EudraLex V27 - February 2013
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an
integrated search engine . The Eudralex V27 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf format and without protection. For a non-commercial use, Eudralex V27 may be duplicated, shared and the documents may be printed. 19 February 2013Responses 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.
24 January 2013Commission 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
22 January 2013Technical 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
17 January 2013Revision 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 [dot] europa [dot] eu (ADM-GMDP[at]ema[dot]europa[dot]eu) and SANCO-pharmaceuticals-D6ec [dot] europa [dot] eu (SANCO-pharmaceuticals-D6[at]ec[dot]europa[dot]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
20 December 2012Public consultation on advanced therapy medicinal products
Stakeholders are invited to provide their views on the application of the Advanced Therapy Regulation at SANCO-ADVANCEDTHERAPY-REPORTec [dot] europa [dot] eu (SANCO-ADVANCEDTHERAPY-REPORT[at]ec[dot]europa[dot]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
28 November 2012Pharmacovigilance - Public consultation on post-authorisation efficacy studies
22 November 2012Commission facilitates importation of pharmaceutical active substances from Switzerland
21 November 2012Pharmacovigilance - Public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring
26 October 2012Quality 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
17 October 2012Concept 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
10 October 2012Update of application form for renewal of marketing authorisation (human and veterinary)
19 September 2012Medicines for children - Public consultation on the experience acquired with the paediatric regulation
06 September 2012Public 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.
06 September 2012Publication of chapter 1, chapter 7 and Annex 2 of the detailed guidelines of the good manufacturing practices
09 August 2012Application of Articles 28(3), 36 and 37 of Regulation 1901/2006
25 July 2012New rules on importing active pharmaceutical ingredients into the EU – information leaflet
18 July 2012Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012
17 July 2012Commission 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
09 July 2012Commission Call for Expression of Interest for the position of Member for the Committee for Advanced Therapies ('CAT') and the Pharmacovigilance Risk Assessment Committee ('PRAC')
20 June 2012Adoption and Publication of Commission Implementing Regulation on pharmacovigilance activities
18 June 2012Public Consultation Paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency
14 June 2012Public 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.
13 June 2012Responses to the public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use
16 April 2012Draft template for the written confirmation for active substances imported into the European Union for medicinal products for human use
Public consultation
12 March 2012Update 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
Responses to the public consultation on the "Revised Commission guidelines on Good Distribution Practice of Medicinal Products for human use"
01 February 2012Outcome of the public consultation on the review of Regulation (EC) 1234/2008
01 February 2012Responses to the Public consultation on the concept paper on implementing measures for the performance of pharmacovigilance activities
20 January 2012Delegated 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.
07 December 2011Implementing 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.
11 October 2011The 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)
30 September 2011Commission 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.
21 September 2011Public Consultation Paper on the review of Regulation (EC) 1234/2008 to the handling of variations to purely national marketing authorisations.
08 September 2011Public 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.
15 July 2011Public 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.
27 June 2011Responses 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”
23 June 2011Responses to the Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC.
14 June 2011Video : 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.
14 June 2011EudraLex - 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’)
27 May 2011Press release: EU adopts ambitious measures to fight against falsified medicines
04 May 2011Medicines 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.
22 March 2011Pharmaceuticals: 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.
18 March 2011EudraLex - 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)
09 February 2011Public 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
07 February 2011EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines : Publication of a revised introduction and the Site Master File
19 January 2011Publication 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.
22 September 2010Clinical trials - Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissions
Publication of submissions
21 June 2010Commission 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’)
11 June 2010Report 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.
01 June 2010Clinical 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 .
01 June 2010Clinical 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.
19 April 2010Public 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-gmdpema [dot] europa [dot] eu (adm-gmdp[at]ema[dot]europa[dot]eu) and ENTR-GMPec [dot] europa [dot] eu (ENTR-GMP[at]ec[dot]europa[dot]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
11 February 2010Responses to the Public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"
22 December 2009Guideline 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.
22 December 2009Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008
Implementation of the Variations Regulation : Communication from the Commission -Guideline on the operation of the procedures laid down in Chapters II, 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.
The EU legal framework for medicinal products guarantees high standards of quality and safety. It also promotes the functioning of the internal market, with measures that encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle with the progressive harmonisation of requirements implemented across the whole European Economic Area.
Today, medicinal products are authorised at EU level by the European Commission or at national level by the competent authorities of EU countries. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials. Once placed on the market, the safety of a medicinal product continues to be monitored throughout its entire lifespan through the EU system of pharmacovigilance.
The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU.