in force 2014-04-25 MODIFIED+12 −112§
Amended by Regulation (EU) No 334/2014 32014R0334
applies from: unchanged
Paragraph 1 no longer requires the applicant to pay the applicable fees under Article 80(1) at the time of submitting the application, removing that phrase from the earlier text.
Paragraph 3 was shortened so that the Agency's notification duty runs only to the applicant, dropping the earlier reference to also informing the evaluating competent authority.
Cited: Art. 54, v1 · Art. 54, v2
text before / after
02012R0528-20130923 → 02012R0528-20140425
Article 54
Assessment of technical equivalence
1. Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (the applicant) shall submit an application to the Agency and pay the applicable fees in accordance with Article 80(1). Agency.
2. The applicant shall submit all data that the Agency requires to assess technical equivalence.
3. The Agency shall inform the applicant of the fees payable under Article 80(1), 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.
4. After giving the applicant the opportunity to submit comments, the Agency shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it to Member States and to the applicant.
5. Where, in the opinion of the Agency, additional information is necessary to carry out the assessment of technical equivalence, the Agency shall ask the applicant to submit such information within a time limit specified by the Agency. The Agency shall reject the application if the applicant fails to submit the additional information within the specified time limit. The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received. The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances.
6. Where appropriate, the Agency may consult the competent authority of the Member State which acted as the evaluating competent authority for the evaluation of the active substance.
7. An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraphs 3, 4 and 5 of this Article.
8. The Agency shall draw up technical guidance notes to facilitate the implementation of this Article.