Administrative amendments - Articles 44 - 45

Applications for administrative amendments are handled nationally and usually does not require updating the Registration Report (RR).

Administrative amendment types:

  1. Transfer of a product to another company
  2. Application for a change of product name
  3. Change of the registration holders adress or company name
  4. Product withdrawal
  5. Change of the name/address of the production site for the product

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 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 formally signed cover letter, which must contain:

a. Effective date of the transfer / revocation of the product authorisation

b. Name and registration number of the current product

c. New name of the product after transfer

d. Copy of "Letter of access"

e. Copy of "Letter of acceptance for the transfer"

f. Copy of "Letter of authorization"

g. Payment information (contact person, e-mail, company address and CVR/VAT number)

  • In order for the new names to be approved, the new registration holder must make sure that:

h. the new product name meets the requirements of the Danish Environmental Protection Agency (DEPA) for advertising

i. 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 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 formally signed cover letter, which must contain:

a. Effective date of the change of product name

b. Name and registration number of the current product, and the new name applied for

c. Payment information (contact person, e-mail, company address and CVR/VAT number)

  • In order for the new names to be approved, the new registration holder must make sure that:

d. the new product name meets the requirements of the Danish Environmental Protection Agency (DEPA) for advertising

e. 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 authorization holder, change address or the company changes name, you must apply for these changes. In addition, the label of authorised products must be updated with the new information (fee type 9236 for the first label, then 9239 per label). If the change of address or name results in a new legal entity, the procedure for transfer of a product must be followed.

The following must be submitted:

  • A complete application form
  • A formally signed cover letter, which must contain: 

a. Effective date of the change of registration holder address or name

b. Payment information (contact person, e-mail, company address and CVR/VAT number)

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 adress 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.

The following must be submitted:

  • A complete application form
  • A formally signed cover letter, which must contain:

a. Trade name and registration number of the product

b. Effective date of the withdrawal

c. Payment information (contact person, e-mail, company address and CVR/VAT number).

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.

The following must be submitted:

  • A complete application form
  • A formally signed cover letter, which must contain:

a. Information about which products are concerned by the changes.

b. Effective date of the changes.

c. 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.

d. Payment information (contact person, e-mail, company address and CVR/VAT number).

Procedure for changes of name/adress 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

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 to or sent to:

Danish EPA, Pesticides and Biocides
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.