Submission of Risk Management Plans (RMP) within the Framework of Regulatory Actions (Marketing authorization applications, Renewals and Variations)

In the interest of harmonizing risk management plans (RMPs) for purely national and DCP/MRP marketing authorisation with Germany as reference member state (DE=RMS), BfArM requests an alignment to the current summary of the risk management plan (RMP summary) to the reference medicinal product or to a comparable medicinal product using the template according to GVP Module V in the current version.

This request applies to the following procedures

1. Marketing authorization applications (e.g. Art. 10(1), 10(3) applications)
2. Renewal-application (if it is intended to submit an RMP)
3. Type II Variations (Changes related to the initial submission or update of the RMP)

Applications according to Art. 8(3) of Dir. 2001/83 are explicitly excluded.

With submission of the above-mentioned applications/submissions, the following declarations must be submitted (within the cover letter, preceding section “<Free text field […]>"):

• The MAA/MAH confirms that the RMP is fully in line with the current “Guideline on good pharmacovigilance practices (GVP) Module V – Risk Management systems" and the “Guidance on format of the risk management plan (RMP) in the EU" <please indicate the applicable revision no.>.
• The MAA/MAH confirms that the summary of safety concerns and all corresponding sections of the RMP, including all risk minimisation measures and pharmacovigilance measures are fully in line with the RMP from the originator (reference marketing authorization or a similar medicinal product as recently adopted by CHMP (EPAR), and/or CMD(h), and/or NCAs published on the respective websites.
  
  Weblink to the relevant RMP Summary of the reference RMP is as follows: <include URL>.
  (If published, the weblink to the referenced RMP summary of the chosen reference medicinal product or similar medicinal product should also be specified.)

An example of a cover letter for a new marketing authorization application can be found here:

An alignment to the "safety concerns" of the most recently approved RMP to the reference medicinal product or a comparable medicinal product is accepted by the BfArM even if the referenced RMP has not yet been prepared according to GMP module V Rev 2. Regardless the current template for RMPs according to GVP Module V, Rev. 2 (EMA /838713/2011 Rev 2 - 28 March 2017) must be used for submission since 01.04.2018.

Summary of Risk Management Plans

The BfArM is consecutively publishing summaries of Risk Management Plans (RMPs) authorised to date. As far as these are available, the links are provided in the drug information system of PharmNet.Bund on the product page of the respective medicinal product. The BfArM is thus complying with its obligation pursuant to Section 34 sub-section 1a of the Medicinal Products Act (Arzneimittelgesetz, AMG).

Further regularly updated information can be found here:

List of published summaries of Risk Management Plans pursuant to Section 34 sub-section 1a AMG

(available in German only)

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