Batch-specific control
Batch-specific control of plasma-derived medicinal products, antisera and immunoprophylactic vaccines
Finnish Medicines Agency (Fimea) is responsible for the batch-specific control of plasma-derived medicinal products, antisera and immunoprophylactic vaccines. Plasma-derived medicinal products are products in which the active pharmaceutical ingredient is derived from human blood or plasma. Antisera are antiseral products produced in animals. In addition, radiopharmaceutical medicinal products containing albumin are also within the scope of batch-specific control, while vaccines used for immunotherapy do not fall within the scope of batch-specific control. Finnish Food Authority is responsible for the control of vaccines, immunoglobulins and antiserums intended for animal use. All documents to Finnish Food Authority should be delivered to [email protected]
According to Fimea regulation 4/2019, either the manufacturer, the marketing authorisation holder or the importer shall submit to Fimea the following information of each vaccine, antiserum or plasma-based medicinal product batch intended for sale in the Finnish market. Batches may be released for the market within 7 work days from the submission of the batch documents, unless Fimea states otherwise. No separate notification of approval will be issued. If batch release is urgently required, this must be mentioned in the cover letter. In this case, Fimea will approve the documentation as soon as possible and issue a separate notification, after which the batch may be released for the market.
Products for which marketing authorisation has been granted:
- Official Control Authority Batch Release certificate (EU-OCABR certificate) issued by the EU's Official Medicines Control Laboratory.
- Marketing Information Form (MIF) signed by a Qualified Person (QP). MIF should include all information regarding the batch to be imported to Finland, including the amount of doses.
Products under special permit/licence:
- Official Control Authority Batch Release certificate (EU-OCABR certificate) issued by the EU's Official Medicines Control Laboratory, if an OCABR procedure for the product exists.
- Marketing Information Form (MIF) signed by a Qualified Person (QP). MIF should include all information regarding the batch to be imported to Finland, including the amount of doses.
or
- Manufacturer's certificate of analysis (if EU-OCABR not available).
- Batch release certificate signed by a QP.
- Declaration on the amount of doses to be imported to Finland.
Additional deliveries:
For an additional delivery of a batch of an already approved vaccine or plasma-derived medicinal product, only the Marketing Information Form (MIF) or other declaration of the batch and amount of doses to be imported to Finland is required.
Clinical trials:
New clinical trials with a permit according to regulation (536/2014) are exempt from batch-specific control.
All information is to be submitted to Fimea, preferably in electronic format, to:
Postal address: P.O. Box 55, FI-00034 FIMEA, FINLAND
Additional information and inquiries:
References:
- 4/2019 Applying for and maintaining a marketing and registration authorisation for a medicinal product, 7.5: Batch-specific control