Frequently asked questions

Handling authorisations are granted for scientific research or research for medicinal purposes, quality control research and product development. In effect, this means that anyone handling narcotic substances or preparations must obtain handling authorisation.

10 Nov 2015

Authorisation for narcotics import and export can be granted to private entrepreneurs, such as pharmaceutical producers, medical wholesalers (subject to wholesale authorisation), pharmacies, hospital pharmacies for the purpose of drug manufacture and other therapeutic uses, legal persons, universities and other research institutes for the manufacture of substances, preparations and test systems used for detecting drugs and for research and product development purposes (see Section 9 of the Narcotics Act 373/2008 and the Section 17, paragraph 1 of the Medicines Act).

Handling authorisation is also required for those applying for narcotics authorisation for medicinal purposes other than those specified in the Medicines Act, the Healthcare Professionals Act and the Veterinary Practice Act. Please see www.finlex.fi.

10 Nov 2015

We recommend that you use your organisation’s terms of reference to complete this section. In the past, shortcomings have been identified in the descriptions setting out the disposal and product defect handling processes.

10 Nov 2015

Fimea recommends that applicants submit a trade register extract with their application. In certain circumstances, Fimea may also require you to submit a copy of the articles of association and other information.

10 Nov 2015

Certificates of solvency are not required as a self-certification process is applied. Please use this form for self-certification purposes: Appendix 1. In the case of limited companies, this must be completed by the managing director and all members of the board. In the case of research institutes, self-certification statements must be provided by unit and/or departmental heads, depending on the organisation structure. The exact requirements for research institutes will be determined on a case-by-case basis.

10 Nov 2015

The responsible person is tasked with ensuring that your organisation complies with its requirements under the Narcotics Act at all times. When appointing the responsible person, please bear in mind that, under the Act, they must also be a signatory to the certificate of disposal and must have sufficient authority to intervene in the event of malpractice or abuse and/or your organisation must have in place a written procedure for such intervention. To ensure that the person appointed is able to carry out the role successfully, their agreement must be sought and their suitability for the role will be assessed.

Fimea approves the appointment of the responsible person and they will be appointed until further notice. In the event that the responsible person resigns, a new responsible person or their substitute must be appointed and approval for the appointment must be sought within seven days, under Section 17, paragraph 3 of the Narcotics Act.

23 Jul 2021

Fimea must be immediately notified of any changes to your organisation’s information. In the event that a new responsible person or a substitute has been appointed, approval for the appointment must be sought within 7 days.

Regular applicants must supply additional information where the last information was supplied more than 12 months ago and no comments were received from Fimea. In this instance, the information must be re-submitted in whole or in part using Appendix 2. Appendix 2 allows applicants to clearly highlight where changes have taken place and to certify that no changes, other than those already stated, have taken place. Please note that self-certificates signed by members of the board and responsible persons under Appendices 1 and 3 must be provided on each occasion.

In summary: all three appendices must be submitted every year. In addition to the signed appendices, further information is only required if changes have been made to the information previously submitted.

Updated on 20 Nov 2023