News and updates on pharmaceuticals
News and updates
Commission report on the use of delegated powers
The Commission transmitted to the European Parliament and the Council a report on the use of delegated powers provided by the EU pharmaceutical legislation. This follows a legal obligation under Directive 2001/83/EC and Regulation (EC) No 726/2004, which requires the Commission to prepare such report every five years.
74th meeting of the Pharmaceutical Committee, 17 March 2015
Eudralex Volume 4,
A new version of Annex 15 has been published. This version will become operational on 1 October 2015.
New guidelines published
The guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use have been published. A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use by 21 March 2016.
The guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use have also been published and come into operation on 21 September 2015.
Notice to applicant, Eudralex Volume 2C
The revision 14.1 of the Guideline on the packaging information of medicinal products for human use authorised by the Union is published.
The update only concerns the annex of the guideline.
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine
Eudralex Volume 1
New version of Eudralex Volume 1
Eudralex Volume 4, Chapters 3 and 5
New versions of Chapter 3 and Chapter 5 have been published providing transitional arrangements for toxicological evaluation. The chapters are otherwise unchanged – apart from an editorial correction of footnote 2 in Chapter 5 – and become operational on 1 March 2015 for all other aspects.
Delegated Regulation on GMP - good manufacturing practice for API - active pharmaceutical ingredient
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 us
General information regarding veterinary medicinal products authorised centralised and nationally (Mutual Recognition and Decentralised procedures) contained in Volume 6A, Chapter 7 General information has been transferred to the EMA and to the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) and the European Medicines Agency (EMA) websites, respectively.
Volume 6C – Regulatory guidelines
The Guideline on Dossier requirements for Type IA and Type IB Notifications Revision 1 (June 2006) has been removed from the website as out-of-date.
There have been some general format changes to the Volume 6 Notice to applicants and regulatory guidelines for medicinal products for veterinary use, but no other substantial amendments.
73rd meeting of the Pharmaceutical Committee, 22 October 2014
New version of Clinical trials
A complete revision of the chapter on clinical trials has been published on the website
Commission 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.
More detailed information and application documents are here.
New Commission guideline on paediatric investigation plans
The Commission publishedon 27 September its new guideline on applications for paediatric investigation plans (PIP) under the Paediatric Regulation (EC) 1901/2006. This update follows a commitment in the 2013 progress report . Amongst other things, it simplifies the structure of the guideline, establishes a list of key elements of a PIP and introduces increased flexibility into the application process. Additionally, new study concepts, such as extrapolation and modelling are better recognised and requirements for the compliance check have been clarified. It is expected that the new guideline will contribute to an efficient and proportionate filing process of paediatric investigation plans.
The text of the guideline is available in all EU languages.
The new guideline is immediatlly applicable as of today. However, until end of 2014 the European Medicines Agency continues to accept paediatric investigation plans that have been prepared in accordance with the previous guideline.
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. The key documents are available here
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine
72nd meeting of the Pharmaceutical Committee, 26 March 2014
New Application Forms for variations and renewals
New application forms for variations and renewals were published on10 June 2014. There is a transitional period of 3 months until the 1st October 2014, after which the new application forms is recommended to be used.
On 24 June 2014 the European Commission adopted the new common logo through an Implementing Regulation. Member States have one year from this date to ensure that the provisions on the common logo are applied. Therefore, by mid-2015, all online pharmacies or retailers legally operating in the EU should display the logo.
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.
Notice to applicants, update of variations and renewal application forms (human and veterinary)
The Notice to Applicants, volumes 2 and 6 have been updated with the publication of the updated application form for the submission of variations and renewal.
Volume 2C : Human medicinal products - Regulatory Guidelines
Volume 6C : Veterinary medicinal products - Regulatory Guidelines
The electronic version of the new variation and renewal application forms are made available by the European Medicines Agency at [http://esubmission.emea.europa.eu/eaf/index.html]
On an annual basis the European Medicines Agency reports on companies and products that have benefitted from the rewards and incentives provided by the Paediatric Regulation No 1901/2006 as well as on companies that have failed to comply with any of the obligations in that Regulation. This report is published by the Commission in accordance with Article 50(1) of the Regulation.
The report covering the year 2013 is available here
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/ECwas published in the Official Journal on 27 May 2014.
Notice 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 and available here.
The Commission has uploaded an online questionnaire regarding the application of Regulation (EC) No 470/2009 of the European Parliament and of the Council on Maximum Residue Limits (MRLs).
The aim of this questionnaire is to gather information from authorities and stakeholders on their experiences with the MRL-Regulation. This information is necessary to establish the report on the experiences gained from the application of the MRL Regulation as required by Article 28 of the Regulation. As of today the MRL questionnaire is published on the Europa website "Your Voice" (link provided below).
It would be very much appreciated if you could take the time to respond to the questionnaire as your answers will provide valuable information to the Commission. Please find below some additional information regarding the MRL questionnaire:
- Questionnaire language: English
- Number of questions: 22 questions and additional comments (mostly closed-ended questions)
- Access to questionnaire
- Deadline for providing answers: May 31 2014 – 20:00 CET
You can only submit/save the questionnaire once it is 100% completed. Therefore, we strongly recommend that you print the questionnaire (pdf format is available online) and prepare the answers in your own time. Once you are ready to submit it you can simply select and copy/paste your answers. You can only stay logged on for a maximum of 60 min.
Should you have any further questions please do not hesitate to contact Alexander Gibbs (e-mail: firstname.lastname@example.org phone: +32 229 13972).
The report on the pharmacovigilance tasks of the European Medicines Agency that were completed the during the first year of application of the EU’s new pharmacovigilance legislation is available here
Responses to the public consultation on the Commission guideline on paediatric investigation plans
A public consultation took place from 9 October 2013 to 3 January 2014 on the Commission guideline on paediatric investigation plans.
Overall, the Commission received 26 responses. A summary of the comments as well as the replies arehere.
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/ECwas adopted on 16 April 2014
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.
Good Distribution praactice
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."
Revision of the Guideline on the format and content of applications for designation as orphan medicinal products
On 28 March, the European Commission published the revised EU 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. The European Commission reviewed the guideline to clarify how sponsors should define the medical plausibly of their product in relation to a disease and its significant benefit. In addition, the electronic submission of an application using the common Food and Drug Administration-European Medicines Agency application form will be possible. During the development of the product, the classification of a disease may change and the designated condition may need to be modified to better reflect the indication that the sponsor intends to request at the time of marketing, therefore, an existing designation can now be amended.
EU 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 (March 2014)
- Annex to 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,date [doc fprmat] - [pdf format]
71th meeting of the Pharmaceutical Committee, 23 October 2013
Revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products
Today the European Commission has launched the public consultation on the revision of Annex 15: Qualification and Validation.
Please consult the privacy statement on this consultation.