(a) "medicinal product" means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals; (b) "product" means the active ingredient or combination of active ingredients of a medicinal product; (c) "basic patent" means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate; (d) "certificate" means the supplementary protection certificate; (e) "application for an extension of the duration" means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric useOJ L 378, 27.12.2006, p. 1 .(f) "maker" means the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out.
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 (Codified version) (Text with EEA relevance )
Modified by
- Actconcerning the conditions of accession of the Republic of Croatia and the adjustments to the Treaty on European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community, 12012J/ACT, April 24, 2012
- Regulation (EU) 2019/933 of the European Parliament and of the Councilof 20 May 2019amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products(Text with EEA relevance), 32019R0933, June 11, 2019
(a) the product is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c) the product has not already been the subject of a certificate; (d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
(a) the acts comprise: (i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or (ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or (iii) the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or (iv) any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.
(b) the maker, through appropriate and documented means, notifies the authority referred to in Article 9(1) in the Member State in which that making is to take place, and informs the certificate holder, of the information listed in paragraph 5 of this Article no later than three months before the start date of the making in that Member State, or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier; (c) if the information listed in paragraph 5 of this Article changes, the maker notifies the authority referred to in Article 9(1) and informs the certificate holder, before those changes take effect; (d) in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging; (e) the maker complies with paragraph 9 of this Article and, if applicable, with Article 12(2).
(a) the name and address of the maker; (b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing; (c) the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place; (d) the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and (e) for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.
(a) that those acts are subject to paragraph 2; (b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in point (a)(i) of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in point (a)(iii) of paragraph 2 could infringe the certificate referred to in paragraph 2 where, and for as long as, that certificate applies.
(a) a request for the grant of a certificate, stating in particular: (i) the name and address of the applicant; (ii) if he has appointed a representative, the name and address of the representative; (iii) the number of the basic patent and the title of the invention; (iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3(b) and, if this authorisation is not the first authorisation for placing the product on the market in the Community, the number and date of that authorisation;
(b) a copy of the authorisation to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC; (c) if the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication; (d) where the application for a certificate includes a request for an extension of the duration: (i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006; (ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.
(a) the name and address of the applicant; (b) the number of the basic patent; (c) the title of the invention; (d) the number and date of the authorisation to place the product on the market, referred to in Article 3(b), and the product identified in that authorisation; (e) where relevant, the number and date of the first authorisation to place the product on the market in the Community; (f) where applicable, an indication that the application includes an application for an extension of the duration.
(a) the name and address of the holder of the certificate; (b) the number of the basic patent; (c) the title of the invention; (d) the number and date of the authorisation to place the product on the market referred to in Article 3(b) and the product identified in that authorisation; (e) where relevant, the number and date of the first authorisation to place the product on the market in the Community; (f) the duration of the certificate.
(a) at the end of the period provided for in Article 13; (b) if the certificate holder surrenders it; (c) if the annual fee laid down in accordance with Article 12 is not paid in time; (d) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorisation or authorisations to place on the market in accordance with Directive 2001/83/EC or Directive 2001/82/EC. The authority referred to in Article 9(1) of this Regulation may decide on the lapse of the certificate either of its own motion or at the request of a third party.
(a) it was granted contrary to the provisions of Article 3; (b) the basic patent has lapsed before its lawful term expires; (c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.
(a) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Bulgaria, provided that the application for a certificate was lodged within six months from1 January 2007 ;(b) any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a medicinal product was obtained: (i) in the Czech Republic after 10 November 1999 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained;(ii) in the Community not earlier than six months prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained;
(c) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Estonia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents granted prior to1 January 2000 , within the six months provided for in the Patents Act of October 1999;(d) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Cyprus prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; notwithstanding the above, where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged within six months of the date on which the patent was granted;(e) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Latvia prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than1 May 2004 ;(f) any medicinal product protected by a valid basic patent applied for after 1 February 1994 and for which the first authorisation to place it on the market as a medicinal product was obtained in Lithuania prior to1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from1 May 2004 ;(g) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Hungary, provided that the application for a certificate was lodged within six months from1 May 2004 ;(h) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Malta prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than1 May 2004 ;(i) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that the application for a certificate was lodged within six months starting no later than1 May 2004 ;(j) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than1 January 2007 ;(k) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovenia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from1 May 2004 , including in cases where the period provided for in Article 7(1) has expired;(l) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or within six months of1 July 2002 if the market authorisation was obtained before that date;(m) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2003 may be granted a certificate in Croatia, provided that the application for a certificate is lodged within six months from the date of accession.
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| Regulation (EEC) No 1768/92 | This Regulation |
|---|---|
| — | Recital 1 |
| Recital 1 | Recital 2 |
| Recital 2 | Recital 3 |
| Recital 3 | Recital 4 |
| Recital 4 | Recital 5 |
| Recital 5 | Recital 6 |
| Recital 6 | Recital 7 |
| Recital 7 | Recital 8 |
| Recital 8 | Recital 9 |
| Recital 9 | Recital 10 |
| Recital 10 | — |
| Recital 11 | — |
| Recital 12 | — |
| Recital 13 | Recital 11 |
| Article 1 | Article 1 |
| Article 2 | Article 2 |
| Article 3, introductory wording | Article 3, introductory wording |
| Article 3, point (a) | Article 3, point (a) |
| Article 3, point (b), first sentence | Article 3, point (b) |
| Article 3, point (b), second sentence | — |
| Article 3, points (c) and (d) | Article 3, points (c) and (d) |
| Articles 4 to 7 | Articles 4 to 7 |
| Article 8(1) | Article 8(1) |
| Article 8(1a) | Article 8(2) |
| Article 8(1b) | Article 8(3) |
| Article 8(2) | Article 8(4) |
| Articles 9 to 12 | Articles 9 to 12 |
| Article 13(1), (2) and (3) | Article 13(1), (2) and (3) |
| Articles 14 and 15 | Articles 14 and 15 |
| Article 15a | Article 16 |
| Articles 16, 17 and 18 | Articles 17, 18 and 19 |
| Article 19 | — |
| Article 19a, introductory wording | Article 20, introductory wording |
| Article 19a, point (a), points (i) and (ii) | Article 20, point (b), introductory wording, points (i) and (ii) |
| Article 19a, point (b) | Article 20, point (c) |
| Article 19a, point (c) | Article 20, point (d) |
| Article 19a, point (d) | Article 20, point (e) |
| Article 19a, point (e) | Article 20, point (f) |
| Article 19a, point (f) | Article 20, point (g) |
| Article 19a, point (g) | Article 20, point (h) |
| Article 19a, point (h) | Article 20, point (i) |
| Article 19a, point (i) | Article 20, point (k) |
| Article 19a, point (j) | Article 20, point (l) |
| Article 19a, point (k) | Article 20, point (a) |
| Article 19a, point (l) | Article 20, point (j) |
| Article 20 | Article 21 |
| Article 21 | — |
| Article 22 | Article 13(4) |
| — | Article 22 |
| Article 23 | Article 23 |
| — | Annex I |
| — | Annex II |
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