Activities of Françoise GROSSETÊTE related to 2014/0257(COD)
Plenary speeches (1)
Veterinary medicinal products (A8-0046/2016 - Françoise Grossetête) (vote) FR
Amendments (5)
Amendment 300 #
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The immediate packaging of a veterinary medicinal product shall contain only the following information listed below. The applicant may include additional information in accordance with Article 30, if the packaging so permits:
Amendment 307 #
Proposal for a regulation
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. The outer packaging of a veterinary medicinal product shall contain only the following information listed below. The applicant may include additional information in accordance with Article 30, if the packaging so permits:
Amendment 316 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
By way of derogation from Article 9, small immediate packaging units shall contain only the following information listed below. The applicant may include additional information in accordance with Article 30, if the packaging so permits:
Amendment 444 #
Proposal for a regulation
Article 34 a (new)
Article 34 a (new)
Article 34a Period of protection of new technical documentation for existing products Any new trials and studies submitted by the holder of a marketing authorisation to the competent authorities for an existing product no longer covered by a data protection period shall have a non-cumulative period of protection of five years, provided that they are: (a) needed to extend a marketing authorisation in respect of species, dosages, pharmaceutical forms or routes of administration, or (b) needed for a re-evaluation requested by the Agency or the competent authorities post-authorisation. No other applicant may use those trials or studies for that five-year period without the written consent of the holder of the marketing authorisation in the form of a letter of access to those trials or studies.
Amendment 692 #
Proposal for a regulation
Article 104 – paragraph 4 a (new)
Article 104 – paragraph 4 a (new)
4a. On the basis of the best practices model that already exists for medicinal products for human use, the Commission is urged to adopt – within 24 months of the entry into force of this regulation – principles and guidelines, to which wholesalers shall be obliged to adhere, for best practices in the wholesale distribution of veterinary medicinal products.