Date: 2023-11-10Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2023/2484 of 9 November 2023 amending Implementing Decision 2012/715/EU as regards the inclusion of Taiwan in the list of third countries established by that Decision
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Decision (EU) 2023/2484, dated 9 November 2023, amends Implementing Decision 2012/715/EU to include Taiwan in the list of third countries with equivalent public health protection standards for active substances exported to the Union. This decision follows a request from Taiwan in 2021 and a subsequent assessment by the Commission, including an onsite review in April 2023. The decision took effect twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Equivalence Assessment:**
* Taiwan requested to be listed as a third country with an equivalent level of public health protection regarding active substances.
* The Commission assessed Taiwan's regulatory system through documentation review and an on-site review conducted in April 2023.
* The Commission concluded that Taiwan fulfills the requirements of Article 111b(1) of Directive 2001/83/EC.
* **Amendment to Implementing Decision 2012/715/EU:**
* The Annex to Implementing Decision 2012/715/EU is replaced, adding Taiwan to the list of countries with equivalent regulatory frameworks.
* **Entry into Force:**
* This Decision entered into force on the twentieth day following its publication in the Official Journal of the European Union (published November 10, 2023).
* **Disclaimer:**
* The Decision should not be interpreted as reflecting any official position of the European Union with regard to the legal status of Taiwan.
ANNEX
* List of third countries with a regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union: Australia, Brazil, Canada, Israel, Japan, South Korea, Switzerland, Taiwan, United States
Impact Analysis:
European Commission:
* Impact: Responsible for the initial assessment and decision-making process regarding Taiwan's regulatory framework. Must implement and monitor the amended decision.
* Action Required: Ensure the updated list of third countries is correctly implemented and monitor Taiwan's compliance.
Taiwan Food and Drug Administration (TFDA):
* Impact: Recognized as having a regulatory framework equivalent to that of the EU for active substances.
* Action Required: Maintain the equivalent standards and cooperate with the EU Commission as needed.
Manufacturers of Active Substances in Taiwan:
* Impact: Easier access to the EU market for active substances.
* Action Required: Continue to comply with Taiwanese regulations, now recognized as equivalent to EU standards.
Manufacturers of Medicinal Products in the EU:
* Impact: Can source active substances from Taiwan with the assurance of equivalent safety and quality standards.
* Action Required: Update sourcing information and potentially diversify supply chains.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Taiwan: A third country requesting assessment of its regulatory framework for active substances exported to the European Union.
Commission Implementing Decision (EU) 2023/2484: The main policy document being analyzed, amending Implementing Decision 2012/715/EU to include Taiwan in the list of third countries.
Implementing Decision 2012/715/EU: A prior Commission Implementing Decision establishing a list of third countries with regulatory frameworks equivalent to the EU for active substances in medicinal products.
Directive 2001/83/EC: A directive of the European Parliament and of the Council on the Community Code relating to medicinal products for human use.
Taiwan Food and Drug Administration (TFDA): The Taiwanese competent authority within the Ministry of Health and Welfare, responsible for regulatory oversight of pharmaceuticals.
Brussels: Location where the Commission Implementing Decision (EU) 2023/2484 was finalized.
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2023/2484 10.11.2023
COMMISSION IMPLEMENTING DECISION (EU) 2023/2484
of 9 November 2023
amending Implementing Decision 2012/715/EU as regards the inclusion of Taiwan* in the list of
third countries established by that Decision
(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 that country’s 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) Taiwan requested, by letter dated 8 December 2021, to be listed in accordance with Article 111b(1) of
Directive 2001/83/EC.
(3) The Commission has assessed the request by carrying on a review of the relevant documentation and an on-site
review of Taiwan’s regulatory system from 20 to 27 April 2023 including an observed inspection and taking due
account of the responses, information and documentation provided during the audit by the Taiwanese competent
authority, Taiwan Food and Drug Administration (TFDA) within the Ministry of Health and Welfare.
(4) Based on that equivalence assessment, the Commission concluded that the requirements of Article 111b(1) of
Directive 2001/83/EC were fulfilled.
(5) Commission Implementing Decision 2012/715/EU(2)should 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.
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.
* This Decision should not be interpreted as reflecting any official position of the European Union with regard to the legal status of
Taiwan.
(1) OJ L 311, 28.11.2001, p. 67.
(2) 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).
ELI: http://data.europa.eu/eli/dec_impl/2023/2484/oj 1/3EN
OJ L, 10.11.2023
Done at Brussels, 9 November 2023.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/dec_impl/2023/2484/ojEN
OJ L, 10.11.2023
ANNEX
‘ANNEX
List of third countries with a regulatory framework applicable to active substances exported to the
Union 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
Canada
Israel(1)
Japan
South Korea
Switzerland
Taiwan
United States
(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.’
ELI: http://data.europa.eu/eli/dec_impl/2023/2484/oj 3/3