Paul-Ehrlich-Institut

01.02.2021: Pub­lic Con­sul­ta­tion: Draft Joint An­nounce­ment by BfArM and Paul-Ehrlich-In­sti­tut for the Fol­low-up of Spon­ta­neous Re­ports of Sus­pect­ed Cas­es of Ad­verse Ef­fects pur­suant to Sec­tion 63c AMG

With the coming into force of the European pharmaceutical package and its transposition into German law with the Second Act for the Amendment of Medicines Law and other Regulations (Zweites Gesetzes zur Änderung arzneimittelrechtlicher und anderer Vorschriften) in 2012, the national announcements applicable until then for the notification and follow-up of reports of adverse effect (last published as 6th announcement on the notification of adverse effects and drug abuse pursuant to Section 63 para 1 to 9 of the German Medicines Act (Arzneimittelgesetz, AMG) were replaced by the European “Guideline on Good Pharmacovigilance Practices” (GVP), especially Module VI ("Collection, management and submission of reports of suspected adverse reactions to medicinal products").

Based on an increasing amount of enquiries, the senior federal authorities in agreement with the Federal Ministry of Health see the need to explain further the requirements described in GVP VI for the follow-up of suspected cases of adverse medicines effects by an announcement with regard to national questions.

The announcement, as planned, is now available as draft.

Now we would like to invite interested parties to comment this draft within a public consultation phase. We would be very happy to receive your comments by 28 February 2021 by email.

Email: uaw@bfarm.de

For the sake of completeness, we would like to indicate that the planned Announcement GVP VI only has the purpose of completing and explaining the specifications contained in it further. The specifications of the European Guideline thus continue to be binding and shall be complied with by all acting pharmaceutical companies to their full extent above all in the scope of the German Medicines Act.

Updated: 01.02.2021