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Supplementary Protection Certificates for Medicinal and Plant Protection Products In Ireland

A Supplementary Protection Certificate (SPC) for a medicinal product or a plant protection product may be sought in any EU State, under Regulation (EC) No. 496/2009, subject to your having obtained a first authorisation to market the product. Equivalent certificates are also available in Iceland, Norway and Liechtenstein.

We would be pleased to supply specific information about applications for SPCs or SPC term extensions (paediatric extensions) in Ireland.

The requirements for filing an Irish SPC are:

  1. The name, address and nationality of the applicant.
  2. The relevant basic Irish patent number, and the title of the invention.
  3. The number and date of the first authorisation to place the product on the market in Ireland, together with a copy of the authorisation that identifies the product. The authorisation should include the summary of the product characteristics listed in Article 4a of Directive 65/65/EEC (pharmaceutical products) or Article 5a of Directive 81/851/EEC (veterinary products), or Article 4 of Directive 91/414/EEC (plant protection products) as appropriate. The name, brand, trade name or other description by which the product is commonly known, must also be indicated.
  4. If the authorisation referred to at (3) is not the first authorisation to place the product on the market in the EU, the number, date and country of the first EU authorisation, together with information establishing the identity of the authorised product are required. Additionally, you must identify the legal provision under which the first authorisation was given, and provide a copy of the notice publishing the authorisation in the appropriate official publication (where appropriate a translation of this notice is also required). Failing such a notice, you should provide any other document proving that the authorisation has been issued, the date on which it was issued and the identity of the product authorised.
  5. Information confirming that the product is covered by the basic patent is required. This may be an indication of a claim of the basic patent that covers the product.
  6. An Authorisation of Agent. Download the Authorisation of Agent form PDF

Irish national rules under the Regulations have been implemented by way of Statutory Instrument No. 307 of 2008.

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