8 Amendments of Sajjad KARIM related to 2018/0161(COD)
Amendment 74 #
Proposal for a regulation
Recital 9
Recital 9
(9) That exception should cover the making of the product, including and of the product which corresponds to the medicinal product protected by a supplementary protectionresulting from such making, which is protected by a certificate in the territory of a Member State, for the exclusive purpose of export of that product or of a medicinal product containing that product to third countries, as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker, where such acts would otherwise require the consent of the certificate-holder, and are strictly necessary for making for the purpose of export or for the actual export itself. For instance, such acts may include the possession, supply and import of active ingredients for the purpose of making thea medicinal product containing that product to which the product covered by the certificate corresponds, or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations.
Amendment 134 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure thatTo prevent circumstances in which holders of supplementary protection certificates already in force are not deprived of their acquired rights, the exception provided for in this Regulation should only apply to certificates that are granted on or after a specified date after entry into force, irrespective of when the application for the certificate was first lodged. The date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way. The date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make, and should take due account of pending applications for certificates.
Amendment 153 #
Proposal for a regulation
Recital 22
Recital 22
(22) This Regulation respects fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union. In particular, this Regulation seeks to ensure full respect for the right to property in Article 17 of the Charter by maintaining the core rights of the supplementary protection certificate, by confinlimiting the exception to certificates granted on or after a specified date after entry into force of this Regulation and by imposing certain conditions on the application of the exception,
Amendment 179 #
(i) making a product, or a medicinal product containing that product for the exclusive purpose of export to third countries; or
Amendment 202 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) the authority referred to in Article 9(1) of the Member State where that making is to take place (‘the relevant Member State’) is notified by the person doing the making (‘the maker’) referred to in point (a) (i) of paragraph 2 of the information listed in paragraph 3 no later than 28 day3 months before the intended start date of making in that Member Stateany related act;
Amendment 212 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 2 – point c
Article 4 – paragraph 2 – point c
(c) the maker ensures that a logo, in the form set out in Annex -II, is affixed to the outer packaging of the product or, if there is no outer packaging, to its immediate packaging product forms part of a medicinal product, the outer packaging of the medicinal product;
Amendment 255 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 469/2009
Article 4 – paragraph 5
Article 4 – paragraph 5
5. Paragraph 2 shall only apply in the case only of certificates granted on or after [OP: please insert the date of the first day of the third month that follows the month in which this amending Regulation is published in the Official Journal)].;
Amendment 257 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 469/2009
Article 11 – paragraph 4
Article 11 – paragraph 4
4. The notification sent to an authority as referred to in Article 4(2)(b9 (1) of the relevant Member State shall publish the information listed in points (a) and (c) of Article 4 (3). It shall also publish any changes to that information that are notified in accordance with the first sentence of point (bc) of Article 4 (2). The remaining information notified under Article 4 (3) shall not be published by thate authority within 15 days of receipt of the notification.; , or made available for inspection by the public, but shall be provided by it, upon request, to a court or other competent authority for the purposes of any legal proceedings in which Article 4 (2) is considered.