Commission regulation (EC) 1234/2008 of 24 November 2008applies from 1 January 2010.This new Variation Regulation establishes new rules for the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, granted in Centralised Procedures (CP), Decentralised Procedures (DCP) or the Mutual Recognition Procedures (MRP). Herewith Regulations 1084/2003/EC and 1085/2003/EC are replaced.

Two Commission guidelines have been issued in connection with the a.m. Regulation:

• “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 ofvariations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.”
• “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”, replacing the former “Guideline on Dossier Requirements for Type IA and Type IB Notifications”

While the first guideline provides detailed operational advice as well as information on the documentation to be submitted, the second provides details of the variation categories (i.e.Type IA, Type IB, Type II), conditions to be fulfilled (if possible) and documentation to be submitted (if possible).

The two guidelines are available on the Web page of the European Commission.

Notice to Applicants, Vol. 2A - Procedures for marketing authorisation, Chapter 5 - Guidelines

An update of the Variation application form is published in EU Electronic Application Forms

Further current information is available on the CMD(h) Web page:

• Best Practice Guides for the Submission and Processing of Variations in Mutual Recognition Procedure
• European Medicines Agency/ CMDh explanatory notes on Variation Application Form
• Question & Answers – List for the Submission of Variations according to Commission Regulation (EC) 1234/2008

Deactivation of the variation branch of the Pharmnet.Bund application "Änderungsanzeigen"

As of 26.10.2023, the previously recommended additional electronic submission of variations according to Regulation (EC) No 1234/2008 via the PharmNet.Bund portal will be discontinued. Due to internal BfArM developments, the submission via the PharmNet.Bund portal is no longer required and will be deactivated as of 26.10.2023. The sending of notifications of changes according to § 29 AMG and other notifications remains unaffected and is still required via the PharmNet.Bund portal.

Variations are to be submitted exclusively via the CESP portal from 26.10.2023. Please note that variations that have already been created but not yet sent can no longer be submitted from this date.

Attention

Applicants can use the following e-mail addresses to contact the BfArM when it is the RMS

• Variation-grouping-IA-number@bfarm.de

  request of a grouped type IA procedure number of the same applicant, if more than one marketing authorisation (e.g. DE/H/0333 and DE/H/0444) are affected by the same Type IA change or same set of type IA changes – ref. CMD(h) Best Practice Guides for the Submission and Processing of Variations in Mutual Recognition Procedure, Chap. 1, para. 6.

• Variation-grouping-request@bfarm.de

  request of a possible grouping of single variations to one application, if the grouping applied for is not listed in Annex III of the Variation Regulation

• Dispatch-Lists@bfarm.de

  for submission of the list of dispatch dates once submission in all CMS is finalised

Worksharing procedures have to be applied for at the CMD(h). Together with the acceptance letter the applicant will be informed about the national competent authority acting as reference authority and the corresponding worksharing procedure number.

For purely national marketing authorisations Article 29 AMG (German Medicines Act) applies until further notice.

The following remarks may be helpful:

• The cover letter to each submission should include, clearly visible, the ATC Code/s of the medicinal product(s). The ATC code for homeopathic and anthroposophical medicines is invariably “V60”. For phytotherapeutic and traditional medicinal products write “Phyto” in the place of the ATC code. The cover letter should include the e-mail address of the person in charge.
• In the variation application form, use the full German name of the medicinal product as it is authorised, and indicate the German marketing authorisation holder as well as the Germanmarketing authorisation number.

• If Type IA or IB variations include alterations of the German texts, submit highlighted and clean versions along with the initial application; this applies to electronic submissions as well (see the AMG-Submission Ordinance).

  For Type II variations only the tracked and clean versions of the English texts (SPC/PL/Labelling) are needed at the time of validation. The amended German texts are not needed before the national phase is started.

• For Type IA variations and those Type IB changes listed in 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” a copy of the relevant section needs to be provided as an annex to the variation application form and the relevant boxes for conditions and documentations need to be ticked.

• For adaptation of the product information to a graduated plan procedure (“Stufenplanverfahren”) or to recommendations of the Pharmacovigilance working party, please consider the recommendations published on our web page "Risk Assessment Procedures".