Batch-specific control

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 numbered in batch-specific control, while vaccines used for immunotherapy do not fall within the scope of batch-specific control.

According to Fimea regulation2/2017, either the manufacturer, the marketing authorisation holder or the importer shall submit to Fimea the following information for each vaccine, antiserum or plasma-based medicinal product batch intended for sale or consumption:

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 includes all information regarding the batch to be imported (e.g. amount of doses to Finland)

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 or a declaration on the batch quantities imported to Finland

or

  • manufacturer's  certificate of analysis (if OCABR not available)
  • batch release certificate signed by a QP
  • declaration on the batch/dose quantities imported to Finland

Clinical trials

According to Fimea regulation 2/2012, either the sponsor of a clinical trial, the coordinator or the importer shall submit to Fimea the following batch documents and information:

A. Investigational new drugs or placebos:

  • manufacturer's batch analysis certificate
  • batch release certificate signed by a QP

B. Products used as a reference or to complement an immunisation programme

  • Official Control Authority Batch Release certificate (EU-OCABR certificate) issued by the EU's Official Medicines Control Laboratory, or the manufacturer's batch analysis certificate
  • batch release certificate signed by a QP

In addition to the batch documents, the supplier shall inform Fimea of all product quantities imported to Finland, the contact information for the researcher in charge of the clinical trial, and the KL and EudraCT numbers of the trial. 

For an additional batch of an already approved vaccine or plasma-derived medicinal product, only the Marketing Information Form (MIF) or other declaration of the batch and quantity to be imported to Finland is required.

All information is to be submitted to Fimea, preferably in electronic format, to:    BATCH.CONTROL@fimea.fi             

For the release of authorised products / products under special permit/licence: Batches may be released for marketing/consumption within 7 work days from the submission of the batch documents, unless Fimea states otherwise. No separate notification of approval will be given. If batch release is urgently required, this must be mentioned in the cover letter. In this case, Fimea will approve the documentation quickly and issue a separate notification, after which the batch may be released for marketing/consumption.

For clinical trials: Fimea will separately approve each batch to be used and issue a separate notification of approval, after which the concerned party may release the product for the trial.

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 batch.release@ruokavirasto.fi