Bijlagen bij COM(2023)222 - Aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen - Hoofdinhoud
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| dossier | COM(2023)222 - Aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen. |
|---|---|
| document | COM(2023)222  |
| datum | 27 april 2023 |
(4) Council conclusions on intellectual property policy of 10 November 2020 https://www.consilium.europa.eu/media/46671/st-12750-2020-init.pdf .
(5) European Parliament, Committee on Legal Affairs, Report on an intellectual property action plan to support the EU’s recovery and resilience (2021/2007(INI)), https://www.europarl.europa.eu/doceo/document/A-9-2021-0284_EN.html .
(6) Discussions in this regard have been taken to the World Intellectual Property Organisation (WIPO), where national/regional patent offices were invited to share information on their collaborations with publicly accessible databases of patent status information concerning medicines and vaccines, such as MedsPaL. See: WIPO, Standing Committee on the Law of Patents, 32nd session, SCP/32/7, 2020.
(7) European Commission, Commission Communication – HERA Incubator: Anticipating together the threat of COVID-19 variants, COM/2021/78, 2021.
(8) European Commission, ‘Questions and answers : HERA incubator – Anticipating together the threat of COVID-19 variants’, 2021 ( https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_642 ).
(9) Case C-58/08 ECLI:EU:C:2010:321.
(10) https://ec.europa.eu/docsroom/documents/29524
(11) https://ec.europa.eu/docsroom/documents/29464
(12) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13353-Medicinal-plant-protection-products-single-procedure-for-the-granting-of-SPCs_en
(13) https://ec.europa.eu/docsroom/documents/29524
(14) https://ec.europa.eu/docsroom/documents/29524/attachments/4/translations/en/renditions/native
(15) To some extent at least, during the transitional period during which non-unitary European patents will still be able to be litigated before national courts.
(16) For a full list of cases, see Table 5.5. of the second MPI study.
(17) Further clarifications are, however, necessary in certain areas as indicated by two referrals in 2022, cases C-119/22 and C-149/22.
(18) Or any other national authority competent for the grant of SPCs.
(19) OJ C […], […], p. […].
(20) OJ C […], […], p. […].
(21) COM(2020)760 final.
(22) Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection (OJ L 361, 31.12.2012, p. 1).
(23) Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 1).
(24) Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, p. 1).
(25) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(26) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
(27) Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).
(28) Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003.
(29) Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1).
(30) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(31) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(32) Convention on the Grant of European Patents of 5 October 1973, as revised on 17 December 1991 and on 29 November 2000.
(33) Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).
(34) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(35) Council Regulation No 1 determining the languages to be used by the European Economic Community (OJ 17, 6.10.1958, p. 385).
(36) Regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products [COM(2023) 231].
(37) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
(38) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).
(39) Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Commission and instituting special measures temporarily applicable to officials of the Commission (OJ L 56, 4.3.1968, p. 1.)’
(40) O.J. reference to be inserted
(41) O.J. reference to be inserted
(42) O.J. reference to be inserted
(43) O.J. reference to be inserted
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EUROPEAN COMMISSION
Brussels, 27.4.2023
COM(2023) 222 final
ANNEXES
to the
Proposal for a Regulation of the European Parliament and of the Council
on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
{SEC(2023) 172 final} - {SWD(2023) 117 final} - {SWD(2023) 118 final} - {SWD(2023) 119 final}
ANNEX I
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This logo shall appear in black and in such a size as to be sufficiently visible.
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EUROPEAN COMMISSION
Brussels, 27.4.2023
COM(2023) 222 final
ANNEX
to the
Proposal for a Regulation of the European Parliament and of the Council
on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
{SEC(2023) 172 final} - {SWD(2023) 117 final} - {SWD(2023) 118 final} - {SWD(2023) 119 final}
ANNEX II
Standard form for notification pursuant to Article 5(3), points (b) and (c).
| Tick the appropriate box | □ New notification □ Update of an existing notification | |
| (a)Name and address of the maker | … | |
| (b)Purpose of making | □ Export □ Storing □ Export and storing | |
| (c)Member State in which making is to take place and Member State in which first related act (if any) prior to making is to take place | Member State of making | |
| (d) | (Member State of first related act (if any)) | |
| (e)Number of unitary certificate having effect in the Member State of making and number of certificate granted in Member State of first related act (if any) prior to making | Unitary certificate having effect in the Member State of making | |
| (Certificate of Member State of first related act (if any)) | ||
| (f)For medicinal products to be exported to third countries, reference number of marketing authorisation, or the equivalent of such authorisation, in each third country of export | ||
| (g) | ||
| (h) |
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