Variation procedures

• E-submission
• Application forms
• Fees
• Useful links
  • COMMISSION REGULATION (EC) No 1234/2008
    http://ec.europa.eu/health/files/eudralex/vol-1/reg_2008_1234/reg_2008_1234_en.pdf
  • Communication from 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
    http://ec.europa.eu/health/files/eudralex/vol-2/c17_1/c17_1_en.pdf
  • CMDh questions and answers http://www.hma.eu/120.html
  • EMA/CMDh explanatory notes on variation application form http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_133_2010_Rev5_Clean_2011_09b.pdf
  • Common Technical document (CTD) questions and answers
    http://ec.europa.eu/health/files/eudralex/vol-2/b/ctd-qa-updatev3_2008-02_en.pdf

• Approved variations
  • Approved national type IA and IB variations (section 6.1.1.)
  • Approved national type II variations (section 6.2.)
  • Approved variations following Refferals (section 6.3.)
  • Approved MRP/DCP variations (section 6.4.1.) 
  • Approved changes in the name of the medicinal products (section 6.5.)
  • Approved changes in the classification of the medicinal products (section 6.1.2.)
  • Approved transfers of the marketing authorisations (section 6.6.)
  • Approved Risk management plans (section 6.7.) 

Variantions approvals

Taking into account MAHs’ comments and necessity to ensure smooth supply of medicinal products authorised via mutual recognition or decentralised procedures (hereinafter - MRP/DCP), the following dates should be indicated in section 10 of the Summary of Product Characteristics and section 6 of the Package Leaflet (hereinafter - PI) :

• Type IA variations – implementation date of Type IA variation should be stated as the last revision date of PI. The MAH is responsible for indicating the correct date in PI;
• Type IB variations - RMS approval date should be stated as the last revision date of PI. The date would be amended by the Agency during the review process of the national translation of PI;
• Type II variations - RMS approval date should be stated as the last revision date of PI. As there is a national phase foreseen, the MAH is responsible for indicating the correct date in PI.

Possible exceptions:

• If changes are related to the transfer of MAH and transfer affects change of the name of the medicinal product – date should be agreed nationally.
• If there are several variations and MAH/Agency wishes one approval date – date will be the latest variation’s RMS approval date.

This concerns only national, not common texts.

The format of the date should be according to the QRD template.

This agreement has been concluded by mutual collaboration and agreement between all Baltic Agencies to ensure common and harmonized approach.

MAH’s are kindly reminded that this agreement and harmonized approach is applicable for MRP/DCP procedures, where Baltic States are involved.

This agreement will enter into force on the 1st of November 2020.

You can find the procedure and requirements for the postponement of variations (grace period) here.