4 Amendments of Lukas MANDL related to 2018/0088(COD)
Amendment 115 #
Proposal for a regulation
Recital 17
Recital 17
(17) Provisions exist on the content of applications for authorisations. It is essential that the application for authorisation submitted to the Authority for its risk assessment meets the applicable specifications to ensure the best quality scientific assessment by the Authority. Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications. It should be thus appropriate that the Authority provides advice to a potential applicant, upon request, on the applicable rules and the required content of an application for authorisation, before an application is formally submitted, while not entering into the design of the studies to be submitted that remain the applicant’s responsibility. To ensure the transparency of this process, the advice of the Authority should be made public.
Amendment 333 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 178/2002
Article 38 – paragraph 1 – point i
Article 38 – paragraph 1 – point i
(i) the general advice provided by the Authority to potential applicants at pre- submission phase pursuant to Article 32a and 32c.
Amendment 341 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – introductory part
Article 38 – paragraph 1 a – introductory part
The disclosure of the information mentioned in paragraph (1)(c) and (i) to the public shall be without prejudice:
Amendment 346 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b
Article 1 – paragraph 1 – point 5 – point b
Regulation (EC) No 178/2002
Article 38 – paragraph 1 a – subparagraph 1 – point a
Article 38 – paragraph 1 a – subparagraph 1 – point a
(a) to any intellectual property right, and the protection of business secrets as referred to in Directive (EU) 2016/943, which may exist overin relation to documents or their content; and,