How to budget marketing of your biocidal product?

I- Regulatory reminders: different approaches to budget for biocides

Authorisation of marketing :

To market your biocidal products, you have to submit an authorisation dossier. There are three types of authorisation of marketing. This can be national, in other words, specific to a single Member State (with the possibility of mutual recognition if you market your product in other countries of the European Union), or may arise from the Union European: we then speak of a EU authorisation.

A- National authorisation

Regarding national authorisation, the applicant shall submit an application to the competent authority of the country. The National Authority has 1 year to validate or reject the request

B- Mutual recognition

After the authorisation, the applicant may then apply for mutual recognition if he wishes to market the product in other EU countries.

C- European Union approval

The authorisation of the Union allows placing biocidal products on the entire European market after a year without obtaining a specific national authorisation. However this authorisation only applies to new active substances. The existing active substances may be permitted only during the regulatory deadlines. The next is 1 January 2017 and concerns the TP 2, 6 and 13. Duration of authorisation : The authorisation is valid for five years, renewal is valid for life. The applicant shall submit an application to the competent authority of the country where it wishes to sell its product. The duration of the authorisation varies depending on the biocidal product. For more information please refer to the table "duration of authorisation" at the bottom of this page.

II- Budgeting: rates in individual cases for the French State

The French government by ministerial decree of 13 June 2014 fixed the amount of compensation due for approval and authorisation of the marketing of biocidal substances and products.

1- EVALUATION OF A DOSSIER REQUESTING APPROVAL OF AN ACTIVE BIOCIDAL SUBSTANCE

In accordance with Article 9 of Regulation (EU) No 528/2012 you must pay the following amounts:

• 200,000 Euros for a type of biocidal product
• 100,000 Euros per additional type of biocidal product
• 120,000 Euros if the active substance is a microorganism (for a biocidal PT)
• 60,000 Euros if the active substance is a microorganism (for an additional biocide PT)

2- EVALUATION OF A DOSSIER APPLICATION FOR RENEWAL OF APPROVAL OF AN ACTIVE SUBSTANCE BIOCIDE

In accordance with Article 14 of Regulation (EU) No 528/2012 you must pay the following amounts:

• 50,000 Euros per additional type of biocidal product
• 60,000 Euros if the active substance is a microorganism (for a biocidal TP)
• 30,000 Euros if the active substance is a microorganism (for an additional biocide TP)

3- EVALUATION OF DOSSIER MARKETING AUTHORISATION

Implementation of 2 of Article 55 of Regulation (EU) No 528/2012:

• If the reference product for the new active substance dossier for which France is the evaluating competent authority you do not have to pay: � 0
• If the reference product folder of the new active substance for which France is not the evaluating competent authority: �40,000

4- EVALUATION OF AN APPLICATION REQUESTING FIRST AUTHORISATION FOR NATIONAL OR UNION MARKETING OF A BIOCIDAL PRODUCT

Implementation of Article 30 or Article 43 of Regulation (EU) No 528/2012:

• 40,000 Euros for a type of biocidal product and user category
• 8000 Euros for a type of biocidal product, by additional user category
• 20,000 Euros for a category of user, by type of additional biocidal product
• 12,000 Euros for a biocidal product strictly identical to the reference product that allowed the approval of the active substance
• 5000 Euros for a product whose marketing has been provisionally authorised (Article 55 � 2 of the Regulation)

5- EVALUATION OF DOSSIER APPLICATION FOR RENEWAL OF FIRST MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT ON THE NATIONAL OR EU MARKET

Implementation of Article 31 or Article 45 of Regulation (EU) No 528/2012:

• 10,000 Euros for a partial evaluation (Article 31)
• 40,000 Euros for a comprehensive assessment

6- EVALUATION OF APPLICATION PACKAGE OF FIRST MARKETING AUTHORIZATION OF A BIOCIDAL PRODUCT

Implementation of Article 25 of Regulation (EU) No 528/2012:

• 12,000 Euros for a type of biocidal product and user category
• 2400 Euros for a type of biocidal product, by additional user category
• 6000 Euros for a category of user, type of additional biocidal product

7- EVALUATION OF RENEWAL OF RECORD FIRST MARKETING AUTHORIZATION OF A BIOCIDAL PRODUCT

Implementation of Article 25 of Regulation (EU) No 528/2012:

• 3,000 Euros for a type of biocidal product and user category
• 800 Euros for a type of biocidal product, by additional user category
• 1500 Euros for a category of user, type of additional biocidal product

8- EVALUATION OF AN APPLICATION REQUESTING A MAJOR CHANGE OF A FIRST MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT

Implementation of Article 25 of Regulation (EU) No 528/2012:

• 6000 Euros for a type of additional product
• 2400 Euros for an additional category of user

9- EVALUATION OF MUTUAL RECOGNITION APPLICATION OF AN AUTHORISATION ISSUED BY ANOTHER MEMBER STATE

Implementation of Articles 33 or 34 of Regulation (EU) No 528/2012:

• 15,000 Euros for a type of biocidal product and user category
• 8000 Euros for a type of biocidal product, by additional user category
• 7500 Euros for a category of user, type of additional biocidal product

10- EVALUATION OF A RENEWAL APPLICATION OF MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT BY MUTUAL RECOGNITION

Implementation of Article 31 of Regulation (EU) No 528/2012:

• 15,000 Euros

11- EVALUATION OF A MINOR AMENDMENT APPLICATION OF MARKETING AUTHORISATION OF BIOCIDAL PRODUCT ON A NATIONAL OR EU MARKET

Implementation of Article 7 of the Implementing Regulation (EU) No 354/2013:

• 2000 Euros

12- EVALUATION OF MUTUAL RECOGNITION APPLICATION OF MINOR CHANGES OF MARKETING AUTHORISATION ON A NATIONAL MARKET

Implementation of Article 9a of Implementing Regulation (EU) No 354/2013:

• 800 Euros

13-EVALUATION OF AN APPLICATION REQUESTING A MAJOR CHANGE OF MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT ON THE NATIONAL OR EU MARKET

Implementation of Article 8 or Article 13 of the Implementing Regulation (EU) No 354/2013:

• 20,000 Euros for a request to add a type of biocidal product
• 8000 Euros for other major change requests

14- EVALUATION OF MUTUAL RECOGNITION APPLICATION OF MAJOR CHANGE OF THE AUTHORISATION ON A NATIONAL MARKET

Implementation of Article 9a of Implementing Regulation (EU) No 354/2013:

• 8,000 Euros for a request to add a biocidal product type
• 3,000 Euros for other requests

15- EVALUATION OR NOTIFICATION OF A CHANGE OF ADMINISTRATIVE APPLICATION OF MARKETING AUTHORISATION ON THE NATIONAL MARKET

In accordance with Article 6 of Implementing Regulation (EU) No. 354-2013:

• 800 Euros

16- EVALUATION OF A MARKETING AUTHORISATION FILE OF THE SAME BIOCIDAL PRODUCT ON THE NATIONAL OR EU MARKET

In accordance with Article 5 or Article 6 of Implementing Regulation (EU) No 414/2013:

17- EVALUATION OF A REQUEST FILE TO REMOVE NATIONAL AUTHORISATION MARKETING OR WITHDRAWAL OF CLASS USER OF A BIOCIDAL PRODUCT TYPE OR OF A USE:

• 0 Euros

18- COMPENSATION OF AN EVALUATION FOR AN APPROVAL FOR MARKETING AUTHORISATION OF A PRODUCT FAMILY IS UP TO 200% OF THE AMOUNT OF THE COMPENSATION FOR THE SAME APPROVAL FOR A BIOCIDAL PRODUCT WITH THE EXCEPTION OF THE EVALUATION OF AN ADMINISTRATIVE AMENDMENT FILE APPLICATION

Implementation of Article 6 of Implementing Regulation (EU) No 354-2013

• 800 Euros

19- NOTIFICATION OF A PRODUCT BELONGING TO A PRODUCT FAMILY

Implementation of Article 17 of Regulation (EU) No 528/2012:

• 800 Euros

20- NOTIFICATION OF RESEARCH AND DEVELOPMENT ACTIVITY

Implementation of 2 of Article 56 of Regulation (EU) No 528/2012

• 800 Euros

21- EVALUATION OF AN APPLICATION DOSSIER FOR MARKETING AUTHORISATION OF AN ACTIVITY RESEARCH AND DEVELOPMENT

Mise en application du 3 de l'article 56 du R�glement (UE) n� 528/2012

• 3000 euros

22- EVALUATION OF A FILE APPLICATION FOR AUTHORISATION OF PARALLEL TRADE

Implementation of Article 53 of Regulation (EU) No 528/2012:

• 1000 Euros by product and country of origin

23- IN THE EVENT OF A COMPARATIVE EVALUATION

Accordance with Article 23 of Regulation (EU) No 528/2012 is required

• 20,000 euros

Table : A substance is approved for the following periods:

Duration of approvalRenewal PeriodActive SubtanceMax 10 yearsMax 15 yearsActive substance fulfilling the criteria for exclusion (Article 5)Max 5 ansNAActive substance that candidates for substitutionMax 7 yearsMax 7 years

Table : Period of authorisation

Biocidal ProductMax 10 yearsBP containing AS which are candidates for substitutionMax 5 yearsBP containing a new AS*Max 3 years

*Under the conditions defined in Article 55 paragraph 2

Need help?

Any questions on your biocidal project? Want to get a detailed quote? Please contact us at contact@ecomundo.eu