Finnish Medicines Agency Fimea
The sponsor of a performance study shall enter and submit an application to Fimea if the study is to be conducted in Finland.
Finnish Medicines Agency Fimea
Fimea issues GMP certificates to Finnish medicinal product manufacturers and competent authorities of export countries for medicinal product exports.
Finnish Medicines Agency Fimea
Fimea may grant a temporary derogation for the placing on the market or putting into service of a medical device.
Finnish Medicines Agency Fimea
All clinical investigations with medical devices under the MD Regulation must be notified to Fimea or be subject to an authorization request.
Finnish Medicines Agency Fimea
The base register of drug products is a register maintained by Fimea concerning licenced drugs and fixed-term products under a special licence.
Finnish Medicines Agency Fimea
Batch-specific control of plasma-derived medicinal products, antisera and immunoprophylactic vaccines
Finnish Medicines Agency Fimea
Upon request, Fimea issues certificates of free sale for medical devices that have been notified to Fimea in the CERE register or to Eudamed.
Finnish Medicines Agency Fimea
Fimea issues marketing authorisation holders with Certificates of a Pharmaceutical Product for export purposes.
Finnish Medicines Agency Fimea
The classification decision is based on an assessment of the effect and presentation of the product.
Finnish Medicines Agency Fimea
Exemption for medicinal product with marketing authorisation/registration critical to Finnish pharmaceutical service, involving risk of interruption.
Finnish Medicines Agency Fimea
Certificates of compliance with the GMP and the GDP for the export of a pharmaceutical factory or wholesale medicinal product
Finnish Medicines Agency Fimea
Fimea’s databases contain information on both human and veterinary medicines and on their rational use.
Finnish Medicines Agency Fimea
Good Laboratory Practice (GLP) is a quality system
Finnish Medicines Agency Fimea
Import and export licences for substances or preparations (pharmaceutical preparation) qualified as narcotic drugs.
Finnish Medicines Agency Fimea
Informal Regulatory Guidance provides information on regulatory instructions related to drug development
Finnish Medicines Agency Fimea
A channel maintained by pharmaceutical sector operators and patient organisations for finding reliable pharmaceutical information on social media.
Finnish Medicines Agency Fimea
Licences relating to industrial production of pharmaceuticals are pharmaceutical plant, contract manufacturing, and contract analysing licence.
Finnish Medicines Agency Fimea
After a marketing authorisation has been granted, the holder of a marketing authorisation is obliged to actively maintain the marketing authorisation.
Finnish Medicines Agency Fimea
All medicinal, veterinary medicinal and herbal medicinal products sold in Finland require a marketing authorisation from Fimea or the EMA.
Finnish Medicines Agency Fimea
Fimea offers free advice on planned clinical investigations with medical devices in Finland.
Finnish Medicines Agency Fimea
Medical device manufacturers must report incidents, and the procedure depends on the event and the applicable legislation.
Finnish Medicines Agency Fimea
Before selling or placing a device on the market, the operator must notify Fimea of its operations and devices in the CERE or EUDAMED register.
Finnish Medicines Agency Fimea
Licence under the Medicines Act (395/1987) for pharmaceutical manufacturers and wholesale distributors operating in Finland.
Finnish Medicines Agency Fimea
Wholesale trade in medicinal products is a subject to a licence issued by Fimea.
Finnish Medicines Agency Fimea
Information submitted by pharmaceutical companies on shortages and their duration is published in the shortage search.
Finnish Medicines Agency Fimea
The Medicines Education Portal is an info package on the use of medicines. It contains study modules and task ideas for basic education teachers.
Finnish Medicines Agency Fimea
The database contains classifications and recommendations for almost 500 medicinal substances or their combinations when used by elderly.
Finnish Medicines Agency Fimea
All clinical investigations with medical devices under the MD Regulation must be notified to Fimea or be subject to an authorization request.
Finnish Medicines Agency Fimea
The manufacturer of a medical device must give notice of an anticipated interruption or discontinuation of the device it manufactures.
Finnish Medicines Agency Fimea
The safety of veterinary medicinal products authorised for sale is monitored, for example, by means of adverse reaction notifications on their use.
Finnish Medicines Agency Fimea
Notified body must seek Fimea’s opinion if EMA opinion is not required.
Finnish Medicines Agency Fimea
Preparation fault must be reported to Fimea that will ensure that the corrective measures are adequate and sufficient.
Finnish Medicines Agency Fimea
Under section 88a of the Medicines Act, prior notice of clinical trials with veterinary drugs to Fimea is required.
Finnish Medicines Agency Fimea
Registration to the NIS2 entity list for operators supervised by Fimea.
Finnish Medicines Agency Fimea
Adverse reactions and risky situations observed in the transfusion, quality or safety of blood products shall be reported to Fimea.
Finnish Medicines Agency Fimea
Scientific advice is provided on the documentation of the quality, efficacy and safety of a medicinal product for human or veterinary use.
Finnish Medicines Agency Fimea
The marketing authorization holder can report a medicine availability disruption to Fimea electronically.
Finnish Medicines Agency Fimea
Fimea directs and supervises blood services in Finland and collaborates with the relevant international authorities.
Finnish Medicines Agency Fimea
Fimea directs and supervises the activities of tissue establishments in Finland and collaborates with the relevant international authorities.
Finnish Medicines Agency Fimea
Organ transplant activity is supervised in Finland by Fimea, Valvira and the Regional State Administrative Agencies.