Forms
Forms: sivun alkuteksti
Fimea forms can be found here and are organised by topic. Some of the forms can be completed electronically and printed, others are available for printing only.
Forms: Marketing authorisation application and notification forms
Application forms for marketing authorisation, marketing authorisation variation and marketing authorisation renewal are available from the European Commission website: Application for marketing authorisation for medicinal products. Part IA / Common technical document (CTD) module 1.2
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Medicinal products for human use (hum)
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Medicinal products for veterinary use (vet)
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Homeopathic remedies (hum)
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Marketing authorisation – application for variation (hum & vet) (hum & vet) (Application form for variation to a marketing authorisation)
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Marketing authorisation – application for renewal (hum & vet) (hum & vet) (Application form for renewal of a marketing authorisation)
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Marketing authorisation – parallel importing (pdf)
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Marketing authorisation – parallel importing (doc)
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MRP RMS request form (doc)
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Application Form for an Exemption (hum, vet) (pdf)
Forms: Sunset clause
Forms: Medicinal products for human use
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Special permission application for compassionate use (pdf)
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Special permission application for compassionate use (doc)
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Adverse drug reaction (ADR) notification (pdf)
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Certification to carry drugs and/or psychotropic substances for treatment purposes – Schengen Implementing Convention – Article 75 (pdf)
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Certification to carry drugs and/or psychotropic substances for treatment purposes – Schengen Implementing Convention – Article 75 (doc)
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Certificate of a Pharmaceutical Product - export (pdf)
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Defective product notification (doc)
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Contact person notification (doc)
Forms: Veterinary medicines
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Adverse drug reaction (ADR) report – veterinary medicines (pdf)
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Adverse drug reaction (ADR) report – veterinary medicines (doc)
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Special permission application for compassionate use, (veterinary medicines) (pdf)
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Special permission application for compassionate use, (veterinary medicines) (doc)
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Advance notification of clinical trial on veterinary medicinal products (pdf)
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Advance notification of clinical trial on veterinary medicinal products (doc)
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Certificate of a Pharmaceutical Product - export (pdf)
Forms: Narcotics
Self-certification templates – authorisation for the import, export, manufacturing and handling of narcotic substances:
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Appendix 1: Self-certification for persons set out in Section 11, paragraph 1, clause 2 of the Narcotics Act (373/2008) (FI) (pdf)
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Appendix 2: Self-certification for persons regularly applying for authorisation for the import, export, manufacturing and handling of narcotic substances (FI) (pdf)
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Appendix 3: Self-certification for persons responsible and their substitutes set out under Section 16 of the Narcotics Act (373/2008) (FI) (pdf)