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What documents are needed for authorization of PPPs by mutual recognition procedure?

The documents required for authorization of PPPs by mutual recognition are as follows:

  • A cover letter with a list of the documents submitted;
  • A mоdel application form in Bulgarian;
  • A copy of the registration certificate, issued by the reference country, officially translated into Bulgarian;
  • Registration report from the reference country;
  • A letter of access /where needed/;
  • Draft label of the PPP;
  • Safety data sheet of the PPP;
  • A receipt for taxes paid.

What documents are needed for authorization of PPPs by zonal procedure?

The documents required for authorization a PPP by zonal procedure are as follows:

  • A Notification form, and a cover letter in Bulgarian to the attention of the Executive Director of the BFSA;
  • A model application form in Bulgarian;
  • draft Registration Report /dRR/;
  • Draft label in Bulgarian;
  • A project of the safety data sheet in Bulgarian;
  • A receipt of taxes paid.

What are the requirements in Bulgaria for authorization of a parallel trade of PPPs?

The requirements are as follows:

  • The Applicant should possess a mаrketing authorization for plant protection products in the country;
  • The product claimed should be registered in Bulgaria /the so called reference product/ and in the country, EU member, where the parallel trade will be carried out;
  • The product claimed and the product of origin have to be identical;
  • The product claimed and the reference product should have different names.

What documents are needed for authorization of parallel trade of PPPs in Bulgaria?

The documents required for authorization of parallel trade of PPPs in Bulgaria are as follows:

  • A cover letter with a list of the documents submitted;
  • A mоdel application form in Bulgarian;
  • A copy of the permission to place the PPP on the market;
  • A receipt of taxes paid;
  • A copy and a translation of the text in Bulgarian of the approved label of the PPP in the country, member of the EU;
  • A draft label for Bulgaria.
  • A safety data sheet in Bulgarian;
  • A sample of the product at BFSA request;
  • Additional information at BFSA request.

Where can I find the active substancies approved to be used in PPPs according the Regulation (EC) № 1107/2009

The approved substances list is to be found in the Regulation EU № 540/2011.


What are the European Union countries in the south zone?

The countries that belong to the south zone are: Bulgaria, Greece, France, Italy, Cyprus, Malta and Portugal.


Are the terms for the different procedures set in the Regulation  (EC) № 1107/2009 strictly kept in Bulgaria?

It happens that these terms are not always strictly kept.


Is it possible that in Bulgaria a second and a third trade name of an authorized product to be permitted? What are the necessary documents required?

Yes, it is possible. The necessary documents are as follows:

  • A cover letter with a list of the documents submitted;
  • A mоdel application form in Bulgarian;
  • A label of the authorized product;
  • A project of the label with the new trade name;
  • Safety data sheet of the authorized product;
  • A project of the Safety data sheet with the new name;
  • A receipt for taxes paid.