Additional information to be submitted with narcotics licence applications

 

Applications for a licence to import, export, produce or handle narcotic drugs can be submitted using a free-format application. In addition to the application letter, applicants must provide additional information that enables the examination of the conditions for granting the licence in accordance with the provisions of the Narcotics Act.

The list below specifies the additional information that must be submitted in free format to Fimea with all types of narcotics licence application.

There are three forms − Appendix 1, Appendix 2 and Appendix 3 − available to facilitate the submission of additional information in conjunction with the "six-month review" following the initial application. These can be found under "Forms" on the Fimea website.

1. Enterprise details: for example, a copy of the articles of association and Trade Register extract.

2. Information about the applicant's suitability (Section 11 of the Narcotics Act 373/2008), i.e. the details of the entrepreneur, persons who are members of the management boards of the applicant and the managing director, co-partner of a partnership, the responsible partners of a limited partnership or the persons holding a managerial post in the unit of a university or other research institute:

2.1. The above persons must provide a written assurance in accordance with the form given in Appendix 1.

3. Free-format description of the activity, including:

3.1. the type and scope of activity under the narcotics licence

3.2. method of narcotic product transport

3.3. method of narcotic product disposal

3.4. description of narcotic product records management

4. Free-format description of the premises and equipment used regarding every site to be covered by the licence, including the following information:

4.1. the address of each site

4.2. the responsible persons for each site to be covered by the licence

4.3. description of storage, access permits and number of personnel.

Sections 16–17 of the Narcotics Act lay down provisions regarding the requirements set for responsible persons and the approval of responsible persons. The following information must be submitted to Fimea for the approval of the responsible person and their deputies:

5. Details of the responsible person and their deputies (section 16 of the Act):

5.1. the responsible person's name and personal identity code

5.2. the responsible person's contact details: email address, phone number, mobile phone number, address

5.3. account of the person's sufficient professional competence acquired through training or experience, such as a curriculum vitae (Experience in the handling of the substances for which the licence is applied should be mentioned specifically.)

5.4. written job description and position in the organisation (This is to verify the responsible person has the powers required for the duty.)

5.5. extract from the Register on Bankruptcies and Reorganisation (omavaraisuustodistus) (Certificate available from the district court to prove the person has not been declared bankrupt. The certificate must have been issued within 3 months of the date of application and its authenticity must be certified; a certified copy is also accepted.)

5.6. extract from the register of guardianship affairs (Certificate available from a local register office proving that the person has not been declared legally incompetent and has not been assigned a guardian. The certificate must have been issued within 3 months of the date of application and its authenticity must be certified; a certified copy is also accepted.)

6. The information specified in section 5 above for the deputy responsible person(s).

Narcotics import and export licences

Applications for import and export licences can be submitted using a free-format application that provides all the relevant information:

  • the importer's name and address (street address);
  • the exporter's name and address (street address);
  • the delivery address of the narcotic product (if different from the above);
  • the delivery address of the licence (if different from the above);
  • details of the substance to be imported/exported (such as name, amount and salt form);
  • details of the preparation to be imported/exported (if imported/exported as a preparation);
  • intended use.

The original import licence issued by the competent authority of the export country or other proof of the legality of import into the country must also be submitted with export licence applications.

Narcotics production licences

Production of narcotics is prohibited without a production licence issued by Fimea. Applications for a narcotics production licence may be free in format but must include the following information:

  • manufacturer's details;
  • the name of the narcotic to be produced;
  • estimated amount to be produced;
  • intended use of the narcotic.

Those applying for a production licence must have a valid handling licence if such licence is required from the applicant under legislation. Consequently, handling licence applications are always processed before production licence applications.

Narcotics handling licences

The handling of narcotics in scientific research or research for therapeutic purposes, quality control studies or product development requires, excluding for the exceptions specified in legislation, a handling licence issued by Fimea. Applications for a narcotics handling licence may be free in format but must include the additional information listed at the top of the page and the following information: details of the narcotics to be handled, their amount and intended use; handling site (street address).

Further information

  • Pihlainen Katja
    Senior Inspector tel. +358295223241