[ParlTrack]

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – introductory part

Subject to a scientific evaluation by the relevant competent authority, the data protection period referred to in paragraph 1 shall be prolonged by: 24 months where

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

(a) ~~24 months, where~~ the marketing authorisation ~~holder demonst~~is grantes that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within three years from that date for any of the following entities:d in relation to a disease in respect of which there is no medicinal product authorised in the Union, or

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – point i

~~(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;~~deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – point ii

~~(ii) entities not engaged in an economic activity (‘not-for-profit entity’); an~~deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a – point iii

(iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)

(a a) in case of the marketing authorisation is granted in relation to a disease in respect of which there has already been a medicinal product authorised in the Union, the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b

(b) six months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c

(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 82 – paragraph 1 – subparagraph 1

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid.deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 82 – paragraph 1 – subparagraph 2

The prolongation referred to in the first subparagraph shall apply to medicinal products that have been granted a centralised marketing authorisation, as referred to in Article 5 or that have been granted a national marketing authorisation through the decentralised procedure, as referred to in Chapter III, Section 3.deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 82 – paragraph 2

2. To receive a prolongation referred to in Article 81(2), first subparagraph, point (a), the marketing authorisation holder shall apply for a variation of the relevant marketing authorisation. The application for a variation shall be submitted between 34 and 36 months after the date when the initial marketing authorisation was granted, or for entities referred to in Article 81(2), first subparagraph, point (a), between 46 and 48 months, after that date. The application for a variation shall contain documentation from the Member States in which the marketing authorisation is valid. Such documentation shall: (a) confirm that the conditions set out in paragraph 1 have been satisfied in their territory; or (b) waive the conditions set out in paragraph 1 in their territory for the purpose of the prolongation. Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74 shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a). _________________ 74 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 82 – paragraph 3

3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State. Within 60 days from the request of the marketing authorisation holder, the Member State shall issue a confirmation of compliance or, a reasoned statement of non- compliance or alternatively provide a statement of non-objection to prolong the period of regulatory data protection pursuant to this Article.deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 82 – paragraph 4

4. In cases where a Member State has not replied to the application of the marketing authorisation holder within the deadline referred to in paragraph 3, it shall be considered that a statement of non-objection has been provided. For medicinal products granted a centralised marketing authorisation the Commission shall vary the marketing authorisation pursuant to Article 47 of [revised Regulation (EC) No 726/2004] to prolong the data protection period. For medicinal products granted a marketing authorisation in accordance with the decentralised procedure, the competent authorities of the Member States shall vary the marketing authorisation pursuant to Article 92 to prolong the data protection period.deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 82 – paragraph 5

5. Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC75 (‘Pharmaceutical Committee’). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee. _________________ 75 Council Decision of 20 May 1975 setting up a pharmaceutical committee (OJ L 147, 9.6.1975, p. 23).deleted

2023/12/01
Committee: ITRE

András GYÜRK, Ernő SCHALLER-BAROSS

Proposal for a directive
Article 82 – paragraph 6

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementing measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 214(2).deleted

2023/12/01
Committee: ITRE

15 Amendments of Ernő SCHALLER-BAROSS related to 2023/0132(COD)

ParlTrack - 2011-2024