Documents

Form comparing the veterinary medicinal product that is to be imported in parallel against the reference veterinary medicinal product

Form | 15-02-2019

Certificate of a Pharmaceutical Product - application instructions

Form | 01-01-2019

Application for Export Certificate

Form | 01-01-2019

Application for exemption for trials with veterinary medicinal products

Form | 01-01-2019

Marketing Information Form, Immunological Veterinary Medicinal Products

Form | 01-01-2019

Question and answer document concerning changes not covered by the Variation Regulation 1234/2008 (as amended by Regulation 712/2012)

Policy document | 05-10-2018

Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU

The delegated Regulation on the characteristics of the safety features and the new medicine verification system will apply as of ...

Publication | 01-10-2018

MEB 8: Guideline on the excipients in the label and the package leaflet of medicinal products for human use

Policy document | 11-09-2018

Overview of proposed withdrawals

At the request of the marketing authorisation holder, the Medicines Evaluation Board (MEB) can withdraw the marketing ...

Publication | 02-07-2018

Declaration by the applicant pertaining to the application for a Duplex marketing authorisation (Model I)

Directive | 18-06-2018