Despite careful quality control procedures, errors can occur in the manufacture of medicines. When errors do occur, products that fail to meet standard quality criteria and which may be harmful to patients can enter the supply chain.
The marketing authorisation holder is primarily responsible for managing product defects. Pharmacies, hospital pharmacies and military pharmacies are responsible for managing any defects in the medicines they produce. All pharmaceutical sector operators are responsible for ensuring that all appropriate measures are in place in the event of a defect. Fimea is tasked with the supervision of all product defect procedures and ensuring that the measures put in place by the operators are appropriate and fit-for-purpose.
The management of product defects is governed by the Medicines Act and the relevant Fimea administrative regulation and guideline. The regulation also applies to counterfeit medicines identified in the legal supply chain.
The Inspectorate under the Fimea Supervision and licences stream is responsible for all matters concerning product defects and counterfeit medicines.
Reporting a product defect
All product defects should be reported by telephone, tel: 029 522 3202 or by e-mail: firstname.lastname@example.org. If the matter is urgent and outside office hours, please contact Fimea by telephone.
All verbal reports must be confirmed in writing. To submit a written report, please use the form available on the Fimea website.
The product defect form and the product defect contact person notification forms can be found under Forms.
Sections 30, 35 a and 101 of the Medicines Act
Contact details (24hrs):
Tel: +358 29 522 3202
Please also see the European Medicines Agency (EMA) contact details for reporting product defects. You are required to inform Fimea of any product defects regarding products authorised under the centralised procedure.