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Legislative, Administrative or Policy Measure (MSR)
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published: 14 Dec 2016 last updated: 11 Oct 2017
General information
Subsidiary Legislation 549.111 - Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation Regulations, 2016
The Subsidiary Legislation 549.111 (Legal Notice 379 of 2016) establishes the role of the Competent National Authority and its obligations and powers, as well as the obligations of users of genetic resources covered by the legal instrument.

The aim of these regulations is to ensure the fair and equitable sharing of the benefits arising from the utilisation of genetic resources for which Malta has sovereign rights, as well as the fair and equitable sharing of benefits arising from local traditional knowledge associated with genetic resources.

These regulations place the national legal regime of the access to genetic resources and the fair and equitable sharing of benefits resulting from their utilisation and lay down provisions required for the implementation of:

(a) Regulation (EU) No. 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union and related implementing Regulations;
(b) the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity; and
(c) Article 15 of the Convention on Biological Diversity;

and shall be read and construed as one with such legal instruments.
National / Federal
Legally binding
08 Nov 2016
Law
No
Amendments
EN
Regulatory contact information
- Competent National Authority: | ABSCH-CNA-MT-208507-1 This document has been updated. This is not the latest published version. Click here to view the latest version of the record.
Competent National Authority:
Plant Health Directorate (Director) ()
110, Annibale Preca Street
Lija,
LJA1915, Malta
Phone: (00356) 2292 6501, (00356) 2292 6500,
Fax:
Website:
Amendments
Relationships
Elements of the measure Collapse All Expand All
  SCOPE OF THE MEASURE
  Genetic Resources
-   Animals , -   Plants , -   Fungi , -   Microorganism , -   Wild species - found in - In-situ Agricultural areas , Dry and sub-humid areas , Forest , Inland waters , Islands , Marine and coastal areas , Protected areas , Ex-situ , Soil and/or water samples (Regulation 2 in its entirety)
  Traditional knowledge associated with genetic resources ( Regulation 6 in its entirety )
  Provisions on temporal scope ( Regulation 2, subregulation 2, paragraph C )
  Reference to any other relevant articles and sections
-  Sovreignty (Regulation 2, subregulation 1)
-  Geography (Regulation 2, subregulation 2, paragraph F)
-  Origin (Regulation 2, subregulation 2, paragraphs A, B, E, G)
-  Law (Regulation 2, subregulation 2, paragraphs A, B, E, D)
  ACCESS
  Access to genetic resources
  For commercial use ( Regulation 5, subregulation 3 )
  For non-commercial use ( Regulation 5, subregulation 3 )
  Access to traditional knowledge associated with genetic resources, including prior informed consent or approval or involvement
  For commercial use ( Regulation 6, subregulation 3 )
  For non-commercial use ( Regulation 6, subregulation 3 )
  Provides for the issuance of a permit of its equivalent at the time of access for constituting an internationally recognized certificate of compliance ( Regulation 5, subregulations 4-5 )
  Established rules and procedures for mutually agreed terms ( Regulation 5, subregulations 2-3 )
  BENEFIT-SHARING
  Monetary benefits ( Regulation 5, subregulation 3 ; Regulation 6, subregulation 3 )
  Non-monetary benefits ( Regulation 5, subregulation 3 ; Regulation 6, subregulation 3 )
  For commercial use ( Regulation 5, subregulation 3 ; Regulation 6, subregulation 3 )
  For non-commercial use ( Regulation 5, subregulation 3 ; Regulation 6, subregulation 3 )
  COMPLIANCE
  Compliance with domestic legislation or regulatory requirements of the other Party (Article 15 and 16) ( Regulation 2, subregulation 4 ; Regulation 10 ; Regulation 13 ; Regulation 14 in its entirety ; Regulation 20 in its entirety ; Regulation 21 in its entirety ; Regulation 22 in its entirety ; Regulation 25 )
  Issues related to monitoring the utilization of genetic resources (Article 17) ( Regulation 15 in its entirety )
  Compliance with mutually agreed terms (Article 18) ( Regulation 20 in its entirety ; Regulation 21 in its entirety ; Regulation 22, subregulation 1, paragraph C and Regulation 22, subregulations 2-6 )
  RELATIONSHIP WITH OTHER INTERNATIONAL INSTRUMENTS
  Plant genetic resources for food and agriculture exchanged using the standard material transfer agreement of the International Treaty on Plant Genetic Resources for Food and Agriculture ( Regulation 2, subregulation 3 )
  Any other element relevant to relationship with other international instrument
-  Pandemic Influenza Preparedness Framework (Regulation 2, subregulation 3)
-  Regulation (EU) No. 511/2014 (Regulation 2, subregulation 4, paragraph A)
-  Other specialised international instruments governing access and benefit sharing of genetic resources (Regulation 2, subregulation 2, paragraph D)
  OTHER
  Competent national authority/ies ( Regulation 4, subregulations 1-2 )
Additional Information
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