Montenegro | BCH-NR3-ME-115704 | Third National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Third National Report on the Implementation of the Cartagena Protocol on Biosafety (NR3)

last updated: 03 Sep 2020
General Information


Administration for Food Safety, Veterinary and Phytosanitary Affairs<br />Ministry of Agriculture and Rural Development<br />Biotechnical Faculty, University of Montenegro
EN

01 Jan 2011
31 Dec 2015
Party to the Cartagena Protocol on Biosafety
Yes
EN
Article 2 – General provisions
A domestic regulatory framework is partially in place
EN
2008
EN
  • One or more national biosafety laws
Yes, to some extent
EN
In the annual program of Phytosanitary measures, each year a component, dedicated to control of seed and planting material on GMO is included, with funds allocated for this purpose from Budget of Montenegro.
EN
No
EN
Partially
EN
Law on GMO (OG of MNE no 22/2008). This is the umbrella law for GMO.
EN
Article 5 - Pharmaceuticals
Yes, to some extent
EN
In the Law on Medicines (OG of MNE no 56/2011) a section dedicated to EXAMINATION OF MEDICINES TO PROVIDE DOCUMENTATION IN THE PROCESS OF AUTHORIZATION OF THE MEDICINAL PRODUCT, paragraph 72 states the following:The (drug and medical agency) Agency shall issue a clinical trial authorization within 60 days of receipt of a complete application with documentation.<br />The period for granting the permit referred to in paragraph 1 of this Article may be extended by a maximum of 30 days, or a total of 90 days, if the clinical trials refer to drugs for gene therapy or somatic cell therapy or to medicines containing genetically modified organisms.
EN
Yes
EN
Article 6 – Transit and Contained use
Yes
EN
Yes
EN
Yes
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
No
EN
No
EN
Yes
EN
No
EN
No
EN
None
EN
None
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes
EN
Yes
EN
Yes
EN
No
EN
No
EN
Article 12 – Review of decision
No
EN
No
EN
No
EN
None
EN
Article 13 – Simplified procedure
No
EN
No
EN
None
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
EN
Articles 15 & 16 – Risk Assessment and Risk Management
Yes
EN
None
EN
None
EN
None
EN
No
EN
No
EN
No
EN
n/a
EN