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WTO notification · TBT

European UnionProposed measure, may since have been adopted

Pharmaceutical products, Veterinary medicines, Food

Official title

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938

The European Union notified this proposed TBT measure to the WTO on 17 February 2026. The comment period closed on 18 April 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

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At a glance

Products

11.120 Pharmaceutics; 11.220 Veterinary medicines 67-Food technology

Notifying member
European Union
Status
Proposed measure, may since have been adoptedNotified as a draft on 17 February 2026. Check WTO ePing or the European Union for its current status.
Objectives
  • National security requirements
  • Consumer information, labelling
  • Prevention of deceptive practices and consumer protection
  • Protection of human health or safety
  • Protection of animal or plant life or health
  • Protection of the environment
  • Quality requirements
  • Harmonization
  • Reducing trade barriers and facilitating trade
  • Cost saving and productivity enhancement
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/EU/1189
ICS classification
  • 11.120 Pharmaceutics
  • 11.220 Veterinary medicine
  • 67 Food technology
Keywords
Human health, Animal health

Key dates

Distributed by the WTO
Comment deadline
Closed on 18 April 2026
Proposed adoption
To be determined
Proposed entry into force
The Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

How to comment

The comment period closed on 18 April 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/EU/1189; it can take them up with the European Union.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

The proposal consists of measures targeted to strengthen the competitiveness of the biotechnology, structured in the following chapters: Chapter I – Subject Matter, Scope and Definitions, sets out the subject matter of this proposal, which consists of measures that articulate its overall objective to improve the functioning of the internal market by establishing a framework to strengthen the competitiveness of the biotechnology sector and specifies the scope of the proposal, which applies to health biotechnology products and services during their entire lifecycle, Chapter II – Union health biotechnology and biomanufacturing, introduces the concepts of health biotechnology strategic projects and high impact health biotechnology strategic projects and establishes a framework for the recognition and the support of such projects aimed at strengthening the EU’s industrial biomanufacturing capacity and value chains. Chapter III – Access to funding, establishes an EU health biotechnology investment pilot in partnership with the European Investment Bank Group and other implementing partners. Chapter IV – Extension of the supplementary protection certificate, introduces an extension of 12 months of the Supplementary Protection Certificate (SPC) for medicinal products developed by means of biotechnology processes and for Advanced Therapy Medicinal Products. Chapter V - Enhancing competitiveness in biosimilars, supports EU competitiveness in the field of biosimilars by encouraging the…

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

All updates from the European Union

  1. WTO notificationTBTProposed measure, open for comments

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  3. WTO notificationTBTProposed measure, open for comments

    Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling…

    The purpose of this draft proposal for a Commission Delegated Regulation under Article 37(7) of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the CLP Regulation) is to amend Table 3 of Part 3 of Annex VI to the CLP Regulation by introducing…

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    Symbol: G/TBT/N/EU/1250Comments until 1 January 2027

  4. WTO notificationSPSProposed measure, open for comments

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    Implementing Regulation 2019/2072 contains the list of Union quarantine pests, protected zone quarantine pests, and regulated non-quarantine pests (RNQPs). Furthermore, it lays down phytosanitary requirements for import and internal movement of plants, plant products and other objects that may…

    Symbol: G/SPS/N/EU/987Comments until 29 December 2026

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