National Authorization Procedures

National authorization procedures
( pursuant to art. 89 “ Transitional measures” of Regulation EU 528/2012 “concerning the making available on the market and use of biocidal products” )
 

The Plant Produce Protection Directorate and its Department of Biocides is the competent authority for biocidal products belonging to the following PTs : 8, 9, 10, 12, 13, 14, 15,16, 17, 18, 19, 21 and 23.

For the remainder of the product types, the competent authority in Greece is the Hellenic Organization for Medicines (responsible person Dr Afroditi Voulgari:

Regarding the authorization requirements during the transitional period (art 89 of the BPR) these are divided as follows: 

a. As far as PT14 and PT18 biocides are concerned, the authorization requirements are described by a relevant Ministerial decision (MD 4829-52048/3-5-2012; please see the attached document in pdf), which is available only in Greek language. Furthermore, the “National” application forms are in Greek, the fees are 1300 € or 3200 € per product (depending on the case described in article 5 of the Ministerial decision. 

b. As far as the biocidal products belonging to the remainder of the PTs (8, 9, 10, 12, 13, 14, 15,16, 17, 18, 19, 21 and 23 ) are concerned the authorization requirements are described by a relevant Ministerial decision (MD 132428/2009 please see the attached document in pdf). 

c. This Ministerial decision is also available only in Greek language. Furthermore, the “National” application forms are in Greek, the fees are 200 €. 

d. Applicants can appoint a local contact point or representative that could undertake this procedure in Greece on their behalf. (including fee payment). 

d. In all cases (either BPR or transitional period), fee payment must be facilitated only by the means of an e-fee-application. More information on the e-fee application for applications during the transitional period can be found in the attached document . 

For more information regarding biocides please contact the competent authority in the email: , tel: +30 210 9287209»