My bookmarksSign up free

Regulation (EU) No 528/2012 Article 36

Regulation (EU) No 528/2012 Article 36

Referral of unresolved objections to the Commission

Article 36

1.   If the Member States referred to in Article 35(2) fail to reach agreement within the 60-day period laid down in Article 35(3), the reference Member State shall immediately inform the Commission, and provide it with a detailed statement of the matters on which Member States have been unable to reach agreement and the reasons for their disagreement. A copy of that statement shall be forwarded to the Member States concerned, the applicant and, where applicable, the authorisation holder. 2.   The Commission may ask the Agency for an opinion on scientific or technical questions raised by Member States. Where the Commission does not ask the Agency for an opinion it shall provide the applicant and, where applicable, the authorisation holder with the opportunity to provide written comments within 30 days. 3.   The Commission shall adopt, by means of implementing acts, a decision on the matter referred to it. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). 4.   The decision referred to in paragraph 3 shall be addressed to all Member States and reported for information to the applicant and, where applicable, the authorisation holder. The Member States concerned and the reference Member State shall, within 30 days of notification of the decision, either grant, refuse to grant or cancel the authorisation, or vary its terms and conditions as necessary to comply with the decision.

Read the full instrument → · Read this in context: CHAPTER VII — MUTUAL RECOGNITION PROCEDURES →

Other provisions in CHAPTER VII — MUTUAL RECOGNITION PROCEDURES

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 36 of Regulation (EU) No 528/2012 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

What to look at next