Date of last update:
Entry in the Provisional List of Biocidal Products
-- PROFESSIONAL AND BUSINESS SERVICES --
Based on the request, a biocide is entered in the temporary list if that biocide has already been put into circulation and use or if the active substance in that biocide is entered in the lists from Article 6 of this law, i.e. if there is no doubt that that biocide represents an unacceptable risk to human health , animals and the environment.
License conditions
Request for entry in the Temporary List of Biocidal Products;
Basic data on the biocide shall be submitted on the form given in Annex 4 of the Rulebook on the content of the technical file and basic data on the biocide with all required attachments in paper and electronic form.
Proof of registration for that activity in the Central Register of Business Entities, other data, at the request of the Agency.
Special requirements for qualifications
Evidence for at least one employee, under whose direct supervision the use, i.e. production, circulation and storage of biocides is carried out, with the completed VII level of the national qualification framework in the fields of: medicine, pharmacy, veterinary medicine, technology, forestry, agronomy, biology or chemistry, depending from the type and purpose of the biocide.
Fees
Administrative fee - €2 to the Agency's giro account 832-31614120-72
Decision on registration in the Temporary list of biocidal products - €40 to the Agency's giro account 832-7075-21.
Competent authorities
Environmental Protection Agency
IV Proleterske 19, Podgorica
Contact phone: 020 446 507
epamontenegro@gmail.com
tatjana.mujicic@epa.org.me
Mail za slanje dokumentacije:
Relevant regulations
Law on Biocidal Products ("Official Gazette of Montenegro", No. 54/16)
Law on Amendments to the Law on Biocidal Products ("Official Gazette of Montenegro", No. 34/24)
Rulebook on types of biocidal products ("Official Gazette of Montenegro", no. 66/16 and 52/19)
Rulebook on lists of active substances that are permitted for use in biocidal products and biocidal products of lower risk ("Official list of the Republic of Montenegro", no. 16/19)
Rulebook on the content of the technical file and basic data on the biocide ("Official Gazette of the Republic of Montenegro" No. 5/17 and 19/18) and Rulebook on Amendments to the Rulebook on the Content of the Technical File and Basic Data on the Biocide ("Official Gazette of the Republic of Montenegro" No. 68/19)
Rulebook on the content of the safety data sheet for chemicals ("Official list of Montenegro", no. 081/17, 021/19)
Permits
Decision on entry into the Provisional List of Biocidal Products
Deadline: While the active substance is approved for use by the European Chemicals Agency (ECHA).
Legal remedies
An appeal can be filed against this decision (permit) to the Ministry of Tourism, Ecology, Sustainable Development and Development of the North, within 15 days from the day of its receipt, through this authority.
Entry in the Provisional List of Biocidal Products
-- PROFESSIONAL AND BUSINESS SERVICES --
Based on the request, a biocide is entered in the temporary list if that biocide has already been put into circulation and use or if the active substance in that biocide is entered in the lists from Article 6 of this law, i.e. if there is no doubt that that biocide represents an unacceptable risk to human health , animals and the environment.
License conditions
Request for entry in the Temporary List of Biocidal Products;
Basic data on the biocide shall be submitted on the form given in Annex 4 of the Rulebook on the content of the technical file and basic data on the biocide with all required attachments in paper and electronic form.
Proof of registration for that activity in the Central Register of Business Entities, other data, at the request of the Agency.
Special requirements for qualifications
Evidence for at least one employee, under whose direct supervision the use, i.e. production, circulation and storage of biocides is carried out, with the completed VII level of the national qualification framework in the fields of: medicine, pharmacy, veterinary medicine, technology, forestry, agronomy, biology or chemistry, depending from the type and purpose of the biocide.
Fees
Administrative fee - €2 to the Agency's giro account 832-31614120-72
Decision on registration in the Temporary list of biocidal products - €40 to the Agency's giro account 832-7075-21.
Competent authorities
Environmental Protection Agency
IV Proleterske 19, Podgorica
Contact phone: 020 446 507
epamontenegro@gmail.com
tatjana.mujicic@epa.org.me
Mail za slanje dokumentacije:
Relevant regulations
Law on Biocidal Products ("Official Gazette of Montenegro", No. 54/16)
Law on Amendments to the Law on Biocidal Products ("Official Gazette of Montenegro", No. 34/24)
Rulebook on types of biocidal products ("Official Gazette of Montenegro", no. 66/16 and 52/19)
Rulebook on lists of active substances that are permitted for use in biocidal products and biocidal products of lower risk ("Official list of the Republic of Montenegro", no. 16/19)
Rulebook on the content of the technical file and basic data on the biocide ("Official Gazette of the Republic of Montenegro" No. 5/17 and 19/18) and Rulebook on Amendments to the Rulebook on the Content of the Technical File and Basic Data on the Biocide ("Official Gazette of the Republic of Montenegro" No. 68/19)
Rulebook on the content of the safety data sheet for chemicals ("Official list of Montenegro", no. 081/17, 021/19)
Permits
Decision on entry into the Provisional List of Biocidal Products
Deadline: While the active substance is approved for use by the European Chemicals Agency (ECHA).
Legal remedies
An appeal can be filed against this decision (permit) to the Ministry of Tourism, Ecology, Sustainable Development and Development of the North, within 15 days from the day of its receipt, through this authority.
