Malta | ABSCH-PRO-MT-248287 | ABS Procedure | Access and Benefit-Sharing Clearing-House

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ABS Procedure (PRO)

last updated: 28 Nov 2022
General information
Description of the ABS Procedure
Obtaining Prior Informed Consent for the access to genetic resources for utilization
EN
National / Federal
- Organization: Plant Protection Directorate (PPD) | ABSCH-CON-MT-208506-7
Organization:
Plant Protection Directorate (PPD)
Government agency (National/Federal)
Genetic Resources Unit 110, Annibale Preca Street
Lija,
LJA1915, Malta
Phone: (00356) 2292 6535,
Fax:
The applicant is required to fill in and submit an application to the Competent National Authority, the type of application depending on whether the intended utilization is academic / conservation research or if it is research and development.
EN
  1. The applicant submits a relevant application to the Competent National Authority (CNA).
  2. Depending on the source location of the genetic resource, the applicant may need to fulfill other permit requirements, such as obtaining a nature permit.
  3. The CNA evaluates the application and determines whether to provide the user with a permit establishing standard PIC / MAT.
  4. Once an ABS permit is provided, the applicant may be required to fulfill reporting requirements during the period of access and utilization.

Refer to the User Guide document for detailed information.
EN
Does the applicant need to provide any documents
Yes
At least the following documents are required:
• Curriculum Vitae of the individual(s) leading the collection of GR / aTK;
• Curriculum Vitae of the individual(s) leading the research or development;
• Detailed project description of the access and utilization activities;
• The name of the repository of genetic resources as well as the identification codes to be assigned to the genetic resources collected, if known at time of application;
• Permission from the third party to enter and collect genetic resources from privately owned land, if applicable;
• Nature Permit from the authority managing the environment if the genetic resource is protected or to be accessed from a protected site.
EN
- Organization: Plant Protection Directorate (PPD) | ABSCH-CON-MT-208506-7
Organization:
Plant Protection Directorate (PPD)
Government agency (National/Federal)
Genetic Resources Unit 110, Annibale Preca Street
Lija,
LJA1915, Malta
Phone: (00356) 2292 6535,
Fax:
Are there application fees
Yes
Some application fees may apply if a nature permit is required.
EN
6 months
ABSCH-MSR-EU-204508-6 Legislative, Administrative or Policy Measure Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices
On the basis of powers granted in Regulation 511/2014 (the "basic" EU ABS Regulation), this Implementing Regulation specifies further the compliance rules established by the basic Regulation and establishes procedures to be followed when applying for recognition of the voluntary compliance support mechanisms.

The Implementing Regulation clarifies when, to whom and which information is to be submitted when filing the due diligence declarations required by the basic Regulation. Furthermore, it establishes the procedures to be followed when a collection applies to become a "registered collection", and when an association of users or other interested parties apply for recognition of "best practices".
 
This Regulation, like the basic Regulation, is directly applicable in all EU Member States and implements the compliance measures of the Nagoya Protocol. Access rules, if established by EU Member States, can be found in the legislation of the respective Member State (see their Country Profiles).

 
ABSCH-MSR-EU-201808-6 Legislative, Administrative or Policy Measure EU ABS Regulation - REGULATION (EU) No 511/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 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 Utilization in the Union

This Regulation establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources in accordance with the provisions of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (the ‘Nagoya Protocol’). The effective implementation of this Regulation will also contribute to the conservation of biological diversity and the sustainable use of its components, in accordance with the provisions of the Convention on Biological Diversity (the ‘Convention’).

This Regulation applies to all EU Member States, regardless of their individual ratification of the Nagoya Protocol.

Due to the division of competences between the EU and its Member States, some elements related to the compliance measures (such as the penalties, authorities in charge of the compliance checks) are not directly provided for in the EU ABS Regulation but are or will be implemented by each EU Member State.

This Regulation implements the obligatory compliance measures of the Nagoya Protocol. It does not establish access rules at EU level. For EU Member States that decide to establish access rules, these will be found in the legislation of the respective EU Member State (see their respective Country Profile).

ABSCH-MSR-MT-208508-3 Legislative, Administrative or Policy Measure 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.
ABSCH-MSR-EU-208044-2 Legislative, Administrative or Policy Measure Commission notice — Guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 of the European Parliament and of the Council on the 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
     
This document is intended to provide guidance on the provisions and implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union (‘the EU ABS Regulation’ or ‘the Regulation’) and Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices (‘the Implementing Regulation’).

The EU ABS Regulation implements in the EU those international rules (contained in the Nagoya Protocol) which govern user compliance — i.e. what users of genetic resources have to do in order to comply with the rules on access and benefit-sharing (ABS) established by the countries providing genetic resources. The Nagoya Protocol also contains rules concerning access measures — but those are not covered by the EU ABS Regulation and accordingly are not addressed in this guidance document.

Certain aspects of the EU ABS Regulation and the Implementing Regulation needed further clarification. The guidance document was developed in cooperation with EU Member States' representatives gathered in the "ABS Expert Group" and it was also subject to feedback from stakeholders gathered in the "ABS Consultation Forum". The guidance document is not legally binding; its sole purpose is to provide information on certain aspects of the relevant EU legislation. It is thus intended to assist citizens, businesses and national authorities in the application of the EU ABS Regulation and the Implementing Regulation.

ABSCH-MSR-MT-257670-1 Legislative, Administrative or Policy Measure Guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 of the European Parliament and of the Council on the 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 2021/C 13/01
This document is intended to provide guidance on the provisions and implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union (1) (‘the EU ABS Regulation’ or ‘the Regulation’).
  • Access to genetic resources (Article 15 of the CBD)
  • Nagoya Protocol
  • Access to genetic resources
  • For commercial use
  • For non-commercial use
  • Mutually agreed terms
  • Access and Benefit-sharing Clearing-House
  • ABS agreements
  • Users of genetic resources
Additional Information
The maximum application timeframe under Subsidiary Legislation 549.111 is of 6 months, however permits are generally processed in less than a few weeks under ordinary circumstances. Timeframes may vary depending on additional permissions required, by example to seek approval from third parties to access managed sites.
EN
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