EU Pharmaceutical informations
Pharmaceuticals Archives - 2012
Health Dialogue between the Russian Federation and the EU on medicinal products: publication of the report "Cooperation in the field of clinical trials"
In the context of the Partnership for Modernization between the Russian Federation and the EU, a specific sectoral group is tasked to work on intensification of cooperation in the interests of modernization in the area of medicinal products.The report "Cooperation in the field of clinical trials" is an important contribution to the work of this group and is now available here
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.
- More informations here
69th meeting of the Pharmaceutical Committee, 22 October 2012
Responses to the public consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency
The new pharmacovigilance legislation: Regulation (EU) No 1235/2010 of 15.12.2010 and Directive 2010/84/EU of 15.12.2010 (OJ 31.12.2010, L348) enables the European Medicines Agency to charge fees for its new pharmacovigilance activities.
The public consultation took place from 18 June 2012 to 15 September 2012. The summary of the comments and the comments received by the European Commission are here.
Public consultation on post-authorisation efficacy studies
Post-authorisation efficacy studies are studies which are undertaken after a medicine has been authorised with the purpose of providing more information on the efficacy of the product within the authorised indications.
Those studies are not an entirely new feature, already now post-authorisation efficacy studies may be conducted. However, with the new pharmacovigilance legislation those studies are formally recognised. It is clarified that marketing authorisation holders can be obliged to conduct such studies by imposing that obligation as a condition to the marketing authorisation. Moreover, competent authorities may require the performance of such studies even post-authorisation, if new scientific evidence indicate that previous efficacy evaluations might have to be revised significantly.
In this context the Commission is empowered to adopt a delegated act laying down the situations in which post-authorisation efficacy studies may be required.
In order to further explore the added-value and the content of such an act the Commission has prepared a reflection paper which is now being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.
The period of consultation ends on 18 February 2013. All citizens and organisations (public and private) are invited to contribute. For more information on how to contribute, please read the reflection paper.
Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation, read the specific Privacy Statement.
Commission facilitates importation of pharmaceutical active substances from Switzerland
Switzerland has today been listed as the first third country with standards in the manufacture of active pharmaceutical ingredients equivalent to those of the EU. After a successful assessment, the European Commission concluded that the regulatory framework applicable to active substances exported to the Union from Switzerland, the respective controls and the enforcement activities are equivalent to those of the Union. This means in practice that Switzerland will not have to issue a 'written confirmation' for each consignment of active substance for medicinal product for human use imported into the EU as of 2 July 2013. The 'written confirmation' aims at verifying that the active substance is manufactured in compliance with standards of good manufacturing practices. Being listed by the European Commission or issuing a 'written confirmation' are two possible options introduced by the Falsified Medicines Directive to ascertain the quality of imported active substances.
- Commission implementing Decision (OJ L 325, 23.11.2012)
- Quality of medicines and Good Manufacturing Practices (GMP)
- Information leaflet
Public consultation on phasing-in requirements on a black symbol identifying medicinal products subject to additional monitoring
Under the new pharmacovigilance provisions some medicinal products for human use are authorised subject to additional monitoring for reasons of their specific safety profile. Those products have to bear a black symbol which shall be selected by the Commission by July 2013 at the latest. In the context of selecting the symbol the Commission is currently considering the need for phasing-in arrangements for the inclusion of the symbol in the summary of product characteristics and the package leaflet of all products concerned.
This concept paper is being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue.
The period of consultation ends on 10 January 2013. All citizens and organisations (public and private) are welcome to contribute to this consultation. For more information on how to contribute, please read the concept paper. Received contributions will be published on the internet. For more information on the processing of personal data in the context of this consultation,read the specific Privacy Statement.
Importation of active substances for medicinal products for human use
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
The Commission has published its Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006.
Update of application form for renewal of marketing authorisation (human and veterinary)
The Notice to applicants, volumes 2C and 6C Regulatory guidelines have been updated with the publication of the updated application form for renewal of marketing authorisation.
The main aim of the update is to take into consideration the changes introduced by Directive 2010/84/EU as regards pharmacovigilance.
Volume 2C : Human medicinal products - Regulatory Guidelines >>>
Pharmaceutical Committee - Summary record of the 68th meeting, 28 March 2012
Medicines for Children
Public consultation on the experience acquired with the paediatric regulation.
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.
Publication of chapter 1, chapter 7 and Annex 2 of the detailed guidelines of the good manufacturing practices
Responses to the concept paper submitted for public consultation concerning the Delegated act on the principles and guidelines of good manufacturing practice for active substances in medicinal products for human use
The responses are available here.
Application of Articles 28(3), 36 and 37 of Regulation 1901/2006
The procedural note explains the impact of the adoption of the new rules on variations on the application of Articles 28(3), 36 and 37 of the Paediatric Regulation is available here.
New rules on importing active pharmaceutical ingredients into the EU – information leaflet
An information leaflet on the new rules on importing active pharmaceutical ingredients into the EU is available here.
Annual report on benefits and infringements under the Paediatric Regulation
In accordance with Article 50(1) of the Paediatric Regulation (Regulation (EC) No 1901/2006 ) the Commission publishes on an annual basis a report prepared by the European Medicines Agency on companies and products that have benefited from the rewards and incentives provided by the Paediatric Regulation as well as on companies that have failed to comply with any of the obligations in that Regulation.
The report covering the year 2011 is available here.
Updated: Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012
More information > > >
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.
More information > > >
The information regarding human medicinal products authorised centrally and nationally (Mutual Recognition Procedure/DeCentralised Procedure) contained in Chapter 7 of volume 2A Notice to applicants-Human is transferred to EMA and CMDh websites respectively. An overview of documents replacing the previous sections of Chapter 7 with corresponding website references is available on these websites. Therefore any reference to chapter 7 should be understood as reference to these webpages. However, guidelines and other interpretative documents to which references may be provided represent the views of their authors.
A similar update will be done for the veterinary sector in the coming months.
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')
This call for expressions of interest relates to the appointment by the Commission of members and alternates representing clinicians and patients' associations at the Committee for Advanced Therapies of the European Medicines Agency [ZIP file with application documents].
This call for expressions of interest relates to the Commission appointments to the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency. With this call the Commission is looking for Representatives of healthcare professionals and patient organisations [ZIP file with application documents].
Adoption and Publication of Commission Implementing Regulation on pharmacovigilance activities
Following its adoption on 19 June the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities has been published in the Official Journal of the European Union. This Implementing Regulation complements the 2010 pharmacovigilance legislation, which starts to apply in July 2012, by providing the more technical details that have to be observed by marketing authorisation holders, national competent authorities and EMA in the daily practice of applying the new legislation. It is therefore an important piece in the new framework, which will promote and protect public health by strengthening the European system for monitoring the safety and use of medicines.
The text of the Implementing Regulation is here
The new pharmacovigilance legislation Regulation (EU) No 1235/2010 of 15.12.2010 and Directive 2010/84/EU of 15.12.2010 (OJ 31.12.2010, L348) enables the European Medicines Agency to charge fees for its new pharmacovigilance activities.
With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on the proposed structure and levels of fees for pharmacovigilance.
- The public consultation paper can be found here. (Deadline for comments: 15 September 2012).
- Questions and Answers (last update : 11/09/2012).
Responses to the public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use
Directive 2011/62/EU to fight against falsified medicines introduces obligatory 'safety features' to allow, inter alia, verification of the authenticity of medicinal products for human use ('unique identifier'). The Directive places the Commission under an obligation to adopt delegated acts setting out the details relating to inter alia the unique identifier. The enclosed concept paper(93 KB) has been launched for public consultation until 27 April 2012 with a view to preparing both the impact assessment and the delegated act
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.
Commission Regulation (EC) No 1234/2008 establishes in its Article 4(2) that the guidelines on the details of the various categories of variations shall be regularly updated, taking into account the recommendations delivered in accordance with Article 5 of this Regulation.
With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on a contribution to the review of the above mentioned guidelines. This contribution is an input from the EU Variation Task Force coordinated by EMA and it will form the basis for the review of the Commission variations guidelines. The public consultation paper can be found here
EudraLex - Volume 10 Clinical trials guidelines
Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
Further to the announcement of 25.04.2012, the European Medicines Agency put on line today an electronic application form allowing to submit initial marketing authorisation applications for veterinary medicines.
This form, 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.
In terms of content, the electronic application form is similar to the current version of the application form published by the European Commission in the EudraLex - Volume 6 - Pharmaceutical Legislation Notice to applicants (NtA). This electronic application form will be updated in parallel to any update of the above mentioned Eudralex- Volume 6.
As a consequence, the e-application form available on the Commission services website is replaced by an external link where this e-application form is available.
Guidance documents applying to clinical trials - Questions & Answers Document, Version 10.0 (April 2012)
The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. The version 10.0 of this document is available here.
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.
In terms of content, the electronic application forms are similar to the current versions of the application forms published by the European Commission in the EudraLex – Volume 2 - Pharmaceutical Legislation Notice to applicants (NtA) and regulatory guidelines medicinal products for human use, as “word” and “pdf” documents
These electronic application forms will be updated in parallel to any update of the above mentioned Eudralex- Volume 2.
As a consequence, the three e-application forms available on Commission services website are replaced by a external link where these e-application forms are available.
Furthermore the following documents have been updated by more recent versions:
- eCTD EU Module 1 ( version 1.4, August 2009) - zip file
- Change Control Process for European eCTD Standards - v1.1 (December 2006)
- Change Control Form - v1.1 (December 2006)
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'.
Pharmaceutical Committee - Summary record of the 67th meeting, 5 October 2011
EudraLex on CD Version 26 - March 2012
Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine.
The Eudralex V26 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 V26 may be duplicated, shared and the documents may be printed.
Questions and answers on transitional arrangements concerning the entering into force of the new pharmacovigilance provisions in July 2012
With the entering into force of the new pharmacovigilance provisions (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) only a few months away, this Q&A documents addresses questions that have been raised to the Commission as regards the correct phasing-in of the new requirements and the specific dates from which the new rules apply. It is intended to facilitate the preparatory work of all stakeholders involved.
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
The adoption of these proposals follows Commissioner Dalli' s announcement on 2 December 2011 at the Council on Employment, Social Policy, Health and Consumer Affairs (EPSCO) of the split of the amended proposals on information to patients, which were adopted on 11 October 2011, into two parts relating to "Information to Patients" and "Pharmacovigilance" respectively. The split of the proposals aims to facilitate the discussion of the proposals by the co-legislators. The four proposals will be now discussed by the European Parliament and the Council of Ministers.
Commissioner Dalli visits the European Medicines Agency in London
Today, Commissioner Dalli visits the European Medicines Agency (EMA) in London. On this occasion Commissioner Dalli will meet the Agency's new Executive Director Guido Rasi who was appointed in October 2011. The mission of Commissioner Dalli to the Agency is meant to contribute to the continued fruitful co-operation between the Commission and its Agency in the best interests of citizens in the EU. The Commission and the Medicines Agency share the great responsibility of ensuring that medicines authorised in the EU are safe and effective.
On the occasion of the Commissioner's visit, the European Commission is launching a video to explain to citizens the system of authorisation for all medicines circulating in the European Union. More >>
Outcome of the public consultation on the review of Regulation (EC) 1234/2008
In October 2011 Directorate General for Health and Consumers consulted stakeholders on the review of the Variations Regulation. In particular, the consultation aimed to collect views on the following items:
- The extension of the scope of the Variations Regulation to purely national marketing authorisations.
- The adjustment of some of the procedures with a view to focus resources of the authorities on variations with the most impact on public health.
Some workability concerns identified.
- Whether, in the light of the experience of last year, the procedure for the authorisation of vaccines in a pandemic setting should be amended.
Responses to the public consultation on the "Revised Commission guidelines on Good Distribution Practice of Medicinal Products for human use"
The responses are published here.
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 paper 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.