Date: 2015-07-02Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2015/1057 of 1 July 2015 amending Implementing Decision 2012/715/EU establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union (Text with EEA relevance)
Executive Summary:
This Commission Implementing Decision EU 2015/1057 amends Implementing Decision 2012/715/EU, updating the list of third countries with regulatory frameworks for active substances in medicinal products for human use that ensure a level of public health protection equivalent to that in the Union. The decision acknowledges requests from Israel and Brazil to be included on the list, and was adopted on July 1, 2015. It enters into force twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Amendment of Implementing Decision 2012/715/EU:** The Annex to Implementing Decision 2012/715/EU, which lists third countries with equivalent regulatory frameworks, is replaced by the text in the Annex to this decision.
* **Inclusion of Israel and Brazil:** Following equivalence assessments, Israel and Brazil are added to the list of third countries ensuring an equivalent level of public health protection. The assessment of Israel took into account the agreement on conformity assessment and acceptance of industrial products between Israel and the Union. The assessment of Brazil took into account the action plan proposed by Brazil on March 12, 2015.
* **Effective Date:** This Decision comes into force on the twentieth day following its publication in the Official Journal of the European Union.
* **List of Third Countries:** The updated list of third countries includes Australia, Brazil, Israel (excluding territories under Israeli administration since June 1967), Japan, Switzerland, and the United States of America.
Impact Analysis:
**European Commission:**
* Impact: Responsible for assessing and updating the list of third countries with equivalent regulatory frameworks.
* Action Required: Ensure the updated list is implemented and communicated effectively.
**Third Countries (Brazil and Israel):**
* Impact: Recognition of their regulatory frameworks as equivalent to that of the Union, facilitating the export of active substances for medicinal products.
* Action Required: Maintain compliance with their established regulatory frameworks.
**Manufacturers of Medicinal Products:**
* Impact: Benefit from a clearer framework for sourcing active substances from listed third countries.
* Action Required: Ensure active substances sourced from third countries comply with the listed countries' regulatory frameworks.
**European Parliament and Council:**
* Impact: Involved in the legislative process related to medicinal products for human use.
* Action Required: Note the amendment to the list of third countries with equivalent regulatory frameworks.
Key Entities Referenced
European Union: The supranational political and economic union of European countries.
Commission Implementing Decision (EU) 2015/1057: Commission Implementing Decision amending Implementing Decision 2012/715/EU regarding third countries with regulatory frameworks for active substances in medicinal products.
Directive 2001/83/EC: Directive of the European Parliament and of the Council on the Community Code relating to medicinal products for human use.
Israel: A country that requested to be listed as having an equivalent regulatory framework for active substances.
Brazil: A country that requested to be listed as having an equivalent regulatory framework for active substances.
Commission Implementing Decision 2012/715/EU: Commission Implementing Decision establishing a list of third countries with equivalent regulatory frameworks for active substances in medicinal products.
Brussels: The location where the decision was adopted.
Australia: A third country with a regulatory framework applicable to active substances for medicinal products for human use.
2.7.2015 EN Official Journal of the European Union L 171/23
COMMISSION IMPLEMENTING DECISION (EU) 2015/1057
of 1 July 2015
amending Implementing Decision 2012/715/EU establishing a list of third countries with a
regulatory framework applicable to active substances for medicinal products for human use and
the respective control and enforcement activities ensuring a level of protection of public health
equivalent to that in the Union
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
Community Code relating to medicinal products for human use (1), and in particular Article 111b(1) thereof,
Whereas:
(1) In accordance with Article 111b(1) of Directive 2001/83/EC a third country may request the Commission to
assess whether its regulatory framework applicable to active substances exported to the Union and the respective
control and enforcement activities ensure a level of protection of public health equivalent to that of the Union in
order to be included in a list of third countries ensuring an equivalent level of protection of public health.
(2) Israel requested, by letter dated 9 May 2012, to be listed in accordance with Article 111b(1) of Directive
2001/83/EC. The equivalence assessment by the Commission concluded that the requirements of that Article
were fulfilled. In exercising this equivalence assessment, account was taken of the agreement on conformity
assessment and acceptance of industrial products (2), as referred to in Article 51(2) of that Directive, between
Israel and the Union.
(3) Brazil requested, by letter dated 4 October 2012, to be listed in accordance with Article 111b(1) of Directive
2001/83/EC. On the basis of a review of relevant documentation and two on-site reviews, and taking due
account of the action plan proposed by Brazil on 12 March 2015, the equivalence assessment by the
Commission concluded that the requirements of that Article were fulfilled.
(4) Commission Implementing Decision 2012/715/EU (3) should therefore be amended accordingly,
HAS ADOPTED THIS DECISION:
Article 1
The Annex to Implementing Decision 2012/715/EU is replaced by the text set out in the Annex to this Decision.
(1) OJ L 311, 28.11.2001, p. 67.
(2) Council Decision 2013/1/EU of 20 November 2012 on the conclusion of a Protocol to the Euro-Mediterranean Agreement establishing
an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on
Conformity Assessment and Acceptance of Industrial Products (CAA) (OJ L 1, 4.1.2013, p. 1).
(3) Commission Implementing Decision 2012/715/EU of 22 November 2012 establishing a list of third countries with a regulatory
framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities
ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European
Parliament and of the Council (OJ L 325, 23.11.2012, p. 15).L 171/24 EN Official Journal of the European Union 2.7.2015
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
Done at Brussels, 1 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX
‘ANNEX
List of third countries with a regulatory framework applicable to active substances for medicinal products for
human use and the respective control and enforcement activities ensuring a level of protection of public health
equivalent to that in the Union
Third country Remarks
Australia
Brazil
Israel(1)
Japan
Switzerland
United States of America
(1) Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan
Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.’