In the decentralised procedure, no prior national marketing authorisation is required. Instead, the pharmaceutical company simultaneously applies for marketing authorisation in all the EU Member States of their choosing, with one Member State taking the lead in this procedure as the so-called Reference Member State (RMS).

The date for the submission of such an application should be agreed with the future RMS in advance.

Validation phase

Before the start of the marketing authorisation procedure, there is a 15-day phase during which the concerned member states (CMS) check whether the application is valid and complete. Information on this can be found on the HMA homepage in the CMDv, CMDv Guidance category.

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The decentralised marketing authorisation procedure

The marketing authorisation procedure consists of two phases. In the first phase, which lasts 120 days, the RMS prepares a preliminary assessment report (PAR) and a list of questions (LOQ) by day 70, which are sent to the applicant and the CMS.

On day 100, the applicant receives further comments from the CMS and prepares a list of questions (LOQ) that takes into account all deficiencies identified by the CMS and the RMS. The LOQ is sent by the applicant to the member states by day 105. This is followed by a clock-off period of three months, which can be extended by a further three months on request. During the clock-off period the applicant responds to the questions raised. The BVL as RMS recommends that critical points are being discussed with the BVL during this period. Please note that it is possible to submit a draft response to the answers in advance. The submission of the final response to the RMS and CMS is referred to as day 106. On day 120, the RMS sends the assessment of the applicant’s response to all parties involved and starts the second phase of the procedure. These start dates are published on the CMDv website.

The second phase takes 90 days. The CMDv has described the decentralised procedure in a Best Practice Guide, which is recommended for further information.

In accordance with Regulation (EU) 2019/6 the Union Product Database has been developed for information on veterinary medicinal products available in the Member States. You can access the UPD here.

An overview of veterinary medicines authorised via the decentralised procedure in the participating member states can also be found on the HMA homepage under VMRI Product Index.

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Re-examination of the assessment report

In accordance with Article 50 (1) of Regulation (EU) 2019/6, the applicant may apply to the RMS for a re-examination of the final assessment report within 15 days of receipt. The request must be made in writing (preferably by email).

Further information on the re-examination procedure can be found on the CMDv website.

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Charging of fees

The information on fees can be found in section 6a, table 1 of the Special Fee Ordinance of the Federal Ministry of Health for individually attributable services in its area of responsibility (Besondere Gebührenverordnung BMG - BMGBGebV)

The fee not only depends on the type of procedure, but also on the involvement of the German Environment Agency (Umweltbundesamt).

A fee according to fee item 1.1 in section 14, subsection 1 of the Special Fees Ordinance of the Federal Ministry of Food and Agriculture for individually attributable public services in its area of responsibility (Besondere Gebührenverordnung BMEL - BMELBGebV) will also be charged for the product classification.

The fees are charged by invoice after the marketing authorization procedure has been concluded.

More information on the Special Fee Ordinance can be found here.

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