The ministerial regulations concerning the marketing authorisation procedures of human (29.03.1996, No 13) and veterinary (08.05.2001, No 49) have been amended to reflect the European law. The regulation No 79 to amend the previous acts was given by the Minister of Social Affairs June 8, 2004 and came into force as of July 1, 2004 (available in Estonian from https://www.riigiteataja.ee/ert/act.jsp?id=770404&replstring=33).

 

Medicinal products for human use

 

A new marketing authorisation application form has been adopted. The new form is a translation of the form from the Notice to Applicants. If the application is submitted in English, the NtA form can be used. Please note that the renewal applications of the nationally authorised products have to be submitted using the marketing authorisation application form (not the NtA renewal form).

 

The CTD format is foreseen for the documentation submitted with the new marketing authorisation applications. In the mutual recognition procedure, where the application has been submitted to the reference member state before November 1, 2003, the documentation may be submitted in the old 4-part EU format until April 30, 2005.

 

Special provisions about the applications concerning the homeopathic products and vitamines are given.

 

An additional fee of 50 000 EEK is introduced to cover the participation of the State Agency of Medicines in the MRP procedure as the reference member state. New fees have also been foreseen for the assessment of variations in case Estonia is the reference member state.

 

Provisions to allow the mutual recognition of marketing authorisations granted in other member states have been introduced in accordance with the Directive 2001/83/EC.

 

The provisions regulating the variations have been changed to reflect the Commission Regulation No 1084/2003. These provisions also apply for the nationally authorised products. A new application form for variations has been adopted. If the application is submitted in English, the NtA form can be used.

 

The full text of the Regulation No 13 as amended is available in Estonian from https://www.riigiteataja.ee/ert/act.jsp?id=775867

 

Medicinal products for veterinary use

 

The EU format as specified in the Annex 1 to the Directive 2001/82/EC is foreseen for the documentation submitted with the new marketing authorisation applications.

 

Provisions to allow the mutual recognition of marketing authorisations granted in other member states have been introduced in accordance with the Directive 2001/82/EC.

 

An additional fee of 50 000 EEK is introduced to cover the participation of the State Agency of Medicines in the MRP procedure as the reference member state. New fees have also been foreseen for the assessment of variations in case Estonia is the reference member state.

 

The full text of the Regulation No 49 as amended is available in Estonian from https://www.riigiteataja.ee/ert/act.jsp?id=776410