PATENT OFFICE OF THE REPUBLIC OF BULGARIA

Application for certificate extension

The application for an extension of the validity of a supplementary protection certificate for medicinal products for pediatric use shall be filed with the Patent Office. It contains an application for an extension of the effect to the Patent Office, which states

  • name of the product for which extension of the certificate is requested;
  • the names and addresses of the applicant ;
  • the names and address of the industrial property representative, if any;
  • correspondence address;
  • data for the application for a supplementary protection certificate - number and date of submission, and in case of already issued certificate, and data for the certificate - number and date of expiration;
  • basic patent data - the title of the invention, the patent number and the expiry date of the patent;
  • details of the authorization to place the product on the market, containing an opinion according to art. 36 (1) of Regulation (EC) № 1901/2006 (or details of the application for authorization).

  • The following shall be attached:

  • a copy of the authorization to place the product on the market in which the product is identified;
  • a copy of the opinion certifying compliance with the adopted completed pediatric study plan;
  • where necessary, in addition to the copy of the authorization to place the product on the market, evidence of possession of the authorization to place the product on the market in all Member States;
  • a copy of a supplementary protection certificate issued, if one has already been issued.

  • Fees determined by the Tariff of Fees shall be paid in connection with the submission of the application, within one month from the date of submission.

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