Applications for administrative amendments are handled nationally and do usually not require updating the Registration Report (RR).
Administrative amendment types
- Transfer of a product to another company
- Application for a change of product name
- Change of the registration holders address or company name
- Product withdrawal
- Change of the name/address of the production site for the product
- Amendment of label
Different requirements to the submission of documentation for applications with administrative changes apply. The requirements are reviewed here:
Requirements for submission of applications
1. Application for transfer of a plant protection product to another company
The authorisation of the product with the old registration number will be revoked with a phasing out period of 6 months for retail sales and an additional 12 months for use and storage from the expiration date of the product registration. If the transferred product is authorised, a new tradename must be assigned to the new product (fee type 9231). If the product is not yet authorised, there is no requirement of changing the name (fee type 9239).
The following must be submitted:
- A complete application form
- A cover letter which must contain:
- Signature
- Effective date of the transfer / revocation of the product authorisation
- Name and registration number of the current product
- New name for the product after transfer
- Confirmation on that the new product name meets the requirements of the Danish Environmental Protection Agency (DEPA) for advertising
- Confirmation on that the new name is not identical to a previously or currently authorised product. Current and previous authorised products can be found in the Environmental Protection Agency’s database (Bekæmpelsesmiddeldatabasen)
- Copy of "Letter of access"
- Copy of "Letter of acceptance for the transfer" signed by the current authorisation holder, including confirmation on the date of revocation of the product authorisation.
- Copy of "Letter of authorization"
Procedure for transfer of a product:
The application is received by the DEPA
The application is screened for any deficiencies
The DEPA confirms reception and indicates whether the application is considered as complete
A fee is charged for the application
Once the fee has been paid, processing of the application commences
The product authorisation under the previous registration holder is revoked with a phasing out period starting from the expiration date of the product registration
The new registration holder is requested to submit a new draft label
The DEPA reviews the label
As soon as the label is approved, an authorisation for the new product is issued and sent to the new registration holder
2. Application for change of product name
If your product has been authorised before, a change of product name will trigger a new registration number (fee type 9231). If your product has NOT been authorised before, a change of product name can be made with the same registration number (fee type 9239). The authorisation of the product with the former reg. no. will be revoked with a phasing out period of 6 months for retail sales and an additional 12 months for use and storage from the expiration date of the product registration.
The following must be submitted:
- A complete application form
- A cover letter which must contain:
- Signature
- Effective date of the change of product name
- Name and registration number of the current product, and the new name applied for
- Confirmation on that the new product name meets the requirements of the Danish Environmental Protection Agency (DEPA) for advertising
- Confirmation on that the new name is not identical to a previously or currently authorised product. Current and previous authorised products can be found in the Environmental Protection Agency’s database (Bekæmpelsesmiddeldatabasen)
Procedure for change of product name
The application is received by the DEPA
The application is screened for any deficiencies
The DEPA confirms reception and indicates whether the application is considered as complete
A fee is charged for the application
Once the fee has been paid, processing of the application commences
The change of product name is accepted and the product authorisation under the former name is revoked with a phasing out period starting from the expiration date of the product registration
The new registration holder is requested to submit a new draft label
The DEPA reviews the label
As soon as the label is approved, an authorisation for the product with the new name is issued and sent to the new registration holder
3. Application for a change of the registration holders address or company name
If you, as the authorisation holder, changes address or the company changes name, you must inform DEPA of these changes (fee type 9231). In addition, the label of authorised products must be updated with the new information (fee type 9232 for the first label, then 9239 per remaining label).
The following must be submitted:
- A complete application form
- A cover letter which must contain:
- Signature
- Effective date of the change of registration holder address or name
- Description of the address- or namechange
Procedure for change of registration holders name or address:
The application is received by the DEPA
The application is screened for any deficiencies
The DEPA confirms reception and indicates whether the application is considered as complete
A fee is charged for the application
Once the fee has been paid, processing of the application commences
The change of name or address is confirmed and the new registration holder is requested to submit a new draft label
The DEPA reviews the label
As soon as the label is approved, an authorisation is issued and sent to the registration holder
4. Application for withdrawal of a product
Withdrawal of a product means that the product authorisation will be terminated with a phasing out period of 6 months for retail sales and an additional 12 months for use and storage from the expiration date of the product registration (fee type 9239).
The following must be submitted:
- A complete application form
- A cover letter which must contain:
- Signature
- Trade name and registration number of the product
- Effective date of the withdrawal
Procedure for product withdrawal:
The application is received by the DEPA
The application is screened for any deficiencies
The DEPA confirms reception and indicates whether the application is considered as complete
A fee is charged for the application
Once the fee has been paid, processing of the application commences
The decision letter is sent to the registration holder by email
The product authorisation is terminated with a phasing out period of 6 months for retail sales and an additional 12 months for use and storage from the expiration date of the product registration
5. Application for a change of the name/address of the production site for the product
If the production site of the product changes address or name, or if an additional production site is desired, the authorisation holder must apply for the change (fee type 9231).
The following must be submitted:
- A complete application form
- A cover letter which must contain:
- Signature
- Information about which products are concerned by the changes
- Effective date of the changes
- Confirmation on that there will be no difference in the formulation composition or source of active substance between the manufacturing sites. The letter must state that the applied changes have no impact on the toxicological, ecotoxicological and physico-chemical properties of the plant protection product.
- Updated part C or doc. J. Please note that the DEPA only accepts part C/doc. J sent electronically in word format, and that all additions must be clearly marked with a color as an update of the product currently accepted part C/doc J.
Procedure for changes of name/address of production site of a product:
The application is received by the DEPA and screened for any deficiencies
The DEPA confirms reception and indicates whether the application is considered as complete
A fee is charged for the application
Once the fee has been paid, processing of the application commences
The decision letter is sent to the registration holder by email
6. Amendment of label
By changing the label for a pesticide product due to either a general change in label text, changed or additional package size, change in label layout or reclassification of the product, an application form must be submitted along with relevant documentation to the Danish Environmental Protections Agency. Fee type 9232 or 9239 will be charged per label depending on the amendments.
The following must be submitted:
- A complete application form
- A cover letter which must contain:
- Signature
- Description of in which section the changes have been made. (e.g. in the warning section or user manual)
- In case of new package size, documentation for identical label must be submitted. Otherwise, draft labels for all package sizes must be submitted
- Draft label as editable PDF-file (ready-to-print, not scanned)
Procedure for amendment of label
- The application is received by the Danish EPA
- A fee is charged for the application
- Once the fee is paid, processing of the application will be initiated
- If there are no comments to the submitted label, approval can be given
Please note the following is relevant for all application types:
It is important that the application is complete and meets all the requirements for the specific type of application.
The application must be emailed (pesticider@mst.dk) or sent to:
Danish EPA, Pesticides
Tolderlundsvej 5
DK-5000 Odense C
Denmark
Pesticide application fees
Fees are charged for the processing and evaluation of applications for amendments of authorisation. Further information can be found under the menu item Fees.
Processing time and decisions
Expected processing time for administrative amendments is 4 weeks.