Exemptions pursuant to section 31 sub-section 1 sentence 2 AMG
C.1. Can applications for exemption be granted with the justification that a medicinal product can/may not be marketed on "public health grounds"?
No. Exemptions can only be granted for medicinal products for which there is a public interest to maintain the marketing authorisation on "public health grounds“, e.g. so that such medicinal products are available in the event of a disaster.
C.2. Are e.g. long processing times of the national competent authority or pending appeal procedures and court actions reasons for granting an exemption if the 3-year period is exceeded for such reasons but the medicinal products cannot be marketed due to these pending procedures?
No. However, a suspension of the 3-year period can be applied for in such cases (for more information cf. Item A.5.).
C.3. Can exemptions pursuant to Section 31 sub-section 1 sentence 2 AMG also be granted for "third countries"?
Exemptions in accordance with Section 31 sub-section 1 sentence 2 AMG can also be granted for export to a third country for public health reasons. The same criteria as for national public health protection apply to the granting of such exemptions.
C.4. Is an exemption granted if the authorised medicinal product from an MR / DC procedure with Germany as RMS has not/no longer been on the German market for more than three consecutive years, but is required in at least one CMS?
Such exemptions can be granted on a case-by-case basis provided the necessary requirements have been fulfilled. Together with the application, the marketing authorisation holder has to prove specifically that the medicinal product is authorised in at least one CMS.
C.5. For which period of time are exemptions granted?
As a rule, the decision on an exemption to the sunset clause is made on a case-by-case basis. Likewise, it is also dependent on the individual case for which period of time the exemption is granted. If the medicinal product is placed on the market again prior to the deadline stated in the BfArM's notice, the exemption to the sunset clause expires. After the deadline stated in the BfArM's notice, the national competent authority will verify upon request, whether the legal requirements for the exemption continue to be applicable.