The Applicant Guide: Parallel Import Procedure
Introduction
This guide sets out the arrangements for approval under the parallel import procedure for the placing on the market and use of plant protection products in GB.
These arrangements replace those issued on 12 September 2006. They are based on draft Guidelines published by the European Commission which are being finalised.
Parallel import
A parallel import is the import of a product which is:
- identical to one that is already approved for placing on the market and use in the UK: and
- approved for placing on the market and use in the country from which it is imported.
The significance of this is that an applicant for a parallel import approval does not need to provide evidence to prove that the product is safe and efficacious, he only needs to provide evidence that the product is identical to one which CRD has already assessed to be safe and efficacious. As a result, the approval procedure is cheaper, quicker and simpler than for a normal approval.
Slightly different rules apply depending whether the product is a parallel import of a product approved under the Plant Protection Products Regulations 2005 (PPPR) or the Control of Pesticides Regulations 1986 (COPR) and whether the parallel import is for placing on the market and use or for “own-use”.
This guide deals with the procedure relating to the commercial approval of parallel imports of products approved under PPPR . An additional guide deals with the approval for own-use of parallel imports of products approved under PPPR. Similar rules apply to products approved under national (COPR) arrangements. Contact CRD for further advice.
Definition of terms used in this Guide
- “EEA state” means a state which is a member of the EU, or Norway, Iceland or Liechtenstein;
- “reference product” means a product approved under PPPR for placing on the market and use in UK. (In the previous guide this was referred to as the “master product”.)
General requirements for a Parallel import
Community legislation on plant protection products does not contain any specific rules about parallel imports. The rules are derived from judgments of the ECJ , which take account of Articles 28 and 30 of the Treaty of Rome.
For a parallel import of a product approved under PPPR there are two requirements:
- the product to be imported must be identical to a UK reference product; and
- the product must be imported from an EEA state where it is approved for placing on the market and use.
Identicality
The most important condition concerning these arrangements is the ‘identicality’ of the imported pesticide product to a product already approved for use in the UK. This means that approval will only be given when the material to be imported is proved not to be ‘materially different’ from the UK-approved reference product. This means that the product to be imported must at least have been manufactured according to the same formulation using the same active ingredient and also to have the same effect with respect to (agriculture) plant health and the environment as the reference product. This can only be done by comparing the formulation of the imported product with that of the reference product including the specification of the active ingredient.
In short CRD will have to be satisfied that the following conditions for establishing identicality are met:
- the formulation type (e.g. granule, emulsifiable concentrate) of the reference product and the parallel-imported are the same;
- the active substance(s) in the parallel-imported product has the same specifications as that in the reference product; and
- the formulation of the product to be imported (including the active substances contained in the formulation) have been manufactured by the same company (or by an associated undertaking, or under licence) as that which manufactures the formulation of the reference product in the UK. This condition is more familiarly known as sharing ‘common origin’.
If you require further advice on the status of the two manufacturers, please contact CRD .
The general criteria employed by CRD in determining identicality are set out in Annex A to these guidelines.
Conditions for placing parallel imported product on the UK market
The product to be imported must be packed and labelled in the form in which it is supplied to the end user in the country from which it is imported.
Bulk supplies of material that have not yet been placed on the market for the end user in the country from which they are imported cannot be approved under this procedure.
Products approved under the procedure may be re-packaged and re-labelled for the UK market subject to the requirements set out below.
Applications
Applicants should submit their application for approval using the application form IDI1 (see also The Applicant Guide) to the Registration Branch Applications Sift, Chemicals Regulation Directorate, Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX. The form must be fully completed with an original declaration signed and dated.
Fees and processing times
Any fees charged or deadlines set for processing commercial parallel import applications will be in accordance with published guidelines operating at the time of application (see our website).
Applications will be considered within a target of 45 working days from the date of receipt of the application. This target time does not include the time required to contact other Regulatory Authorities or, if necessary, the UK reference approval holder.
The fee for parallel import applications covers the sifting, verification, co‑ordination and label check modules (see Fees Guidance Document).
Information supplied by the applicant
As a guide, the application must include:
- name and address of the applicant
- the name of the EEA state from which the product is to be imported, the name of the product and the authorisation number of the product in that state; (to obtain approval to import a product from more than one state, this information must be given in relation to each state from which imports are to be made);
- name of the UK reference product and its approval number;
- written confirmation from the applicant that as far as they are aware the UK reference product and the foreign import share common origin,
It might help to speed up your application if you were able to provide the following:
- names and addresses of the authorisation-holders of the imported product and the reference product
- other useful information in your possession, such as:
- content of active ingredient in the imported product
- type of formulation
- a label from the original product as it appears for the user in the country of origin*
* This can take the form of an actual label, a good clear photocopy, or a copy of a label downloaded from the manufacturer’s website.
In addition to the requirements set out above, you may also submit any other evidence to show that in your opinion the product to be imported is identical to the UK reference product.
Approval status of the reference product
The approval for the reference product does not need to be extant at the time when the application for the parallel import approval is made, provided that;
- the reference product approval was withdrawn for commercial rather than safety or efficacy reasons; and
- no safety or efficacy issues have arisen since its withdrawal; and
- there are no outstanding requirements for the submission of data in respect of the reference product.
Guidance on labels and labelling:
- CRD will check a proposed label only if specifically requested. If a label check is required then you should request this in your covering letter and submit a copy of the proposed product label and a Compatibility Assurance Statement (if tank mixes are to appear on the label). See The Labelling Handbook and the guidance document on tank-mixes for further information.
- the instructions on the label of the parallel import must be consistent with those on the reference product; for example, they must not make any additional claims as to use and safety.
- labels must adhere to UK labelling classification (although there may be a difference in classification, this difference is not part of the identicality test);
CRD will not refuse an application on the basis of non-substantive differences between the label on the imported product and the label on the reference product.
Re-packaging
Approval for repackaging may be given where the applicant is able to demonstrate, with supporting information as necessary, that:
- the original condition of the product including its safety and efficacy is not adversely affected;
- it does not affect the storage stability of the product;
- the chosen container design will not affect operator safety.
Verification procedures
CRD will use a number of procedures to try and verify that the product to be imported is identical to the reference product. [These are set out at Annex B]
Analysis data
Analysis data will not be accepted in support of parallel import applications. This would be outside the scope of the object of the scheme which is to enable the import of identical products without recourse to additional data being required.
In cases where the applicant needs to submit data in support of their application, or in cases where common origin cannot be established, the applicant will need to apply for an approval under a different application stream.
Approval
If approved, the imported product will receive a MAPP approval number and its approval details will be included on the databases available on the CRD website.
The level of approval and date of expiry will be linked to the reference product so that:
- where the reference product holds full approval for certain uses, the imported product will be given full approval for any or all of those uses; and
- where the reference product holds provisional approval for certain uses, for example because there are outstanding data requirements, the imported product will only be given provisional approval for those uses.
However, a parallel import approval may continue after a reference product approval has been withdrawn provided that:
- the withdrawal was for commercial rather than safety or efficacy reasons; and
- no safety or commercial considerations subsequently arise; and
Conditions governing named country/countries of purchase
The approval will specify the country from which the product may be imported, and its authorisation number in that state.
Length of approval
A parallel import approval will be granted for up to a maximum of 10 years (subject to review) dependent upon the continued approval of the reference product in the country of origin. Any subsequent safety issues that arise, e.g. review of the active substance leading to revocation of products containing that active, will result in the revocation of the parallel import product (see All Approval Holder Letter 27/2002).
For approval of the imported product beyond the expiry date, an application for a new approval will be required.
A general point that should be noted is that where a reference product is revoked but the parallel is allowed to continue, the parallel approval will be limited to a maximum period of 10 years.
Post Approval Requirements
When approval for an imported product is given, the approval holder will be required to:
- number sequentially all containers sold in the United Kingdom; and
- ensure that, where repackaging has taken place, each container contains only material from one batch; and
- keep a record of the batch numbers of all products imported, alongside a record of the batch numbers subsequently given to those batches when marketed in the UK. CRD may request that these details be submitted for regulatory purposes or as a result of a safety concern regarding the product;
- keep a record of the registration numbers issued by the country of purchase regulatory authority for the products they import. CRD may request these details at any time to ensure that the formulation of the imported product subject to parallel import approval continues to be supported by an authorisation in the country of purchase; and
- where a product is not immediately available from the country of origin, the applicant must notify CRD when they wish to start importing the product.
In order to ensure that imported products meet the conditions established in the approval, and in particular the criteria regarding identicality, CRD may require the provision of any information it considers necessary at any time after approval has been given for an imported product.
As is the case for all other approved products, CRD will routinely carry out full chemical analysis on a sample of imported products to check that they meet international Food and Agriculture Organisation (FAO) specifications. The approval holder will only be contacted in the event of a problem being identified from the analysis results.
Where CRD establishes that any imported product fails to conform to any condition of approval, the Ministers may revoke or suspend the approval, and order the re-export of the imported product.
Revocation of approvals
An approval will be revoked if:
- the product to be imported ceases to be approved in the state from which it is imported;
- the reference product approval is revoked for safety reasons;
- in the course of a review of the reference product, required data are not submitted;
- in circumstances where the reference product has been withdrawn for commercial reasons, there is a review of the safety and efficacy of the product and the requirements of the review are not met.
No revocation action will be taken following a change to the name of the reference product, or a change to the reference product approval holder or marketing company name.
Refusal of parallel import approval
Where identicality is not established to the satisfaction of CRD during evaluation, approval will be refused, and as far as commercial confidentiality considerations will allow, the reason for refusal will be given. In such cases it is open to the applicant to apply for approval supported by an appropriate data package via a different application stream.
An approval will be refused in circumstances where the reference product approval has been withdrawn for commercial reasons if the active substance in the product is under review.
Additional considerations
Batch variation
Post approval, the imported product will be granted allowance for the same batch-to-batch variation in formulation of the product as is granted to the corresponding reference product.
Transport and handling
All importers should ensure that they comply with any legislation controlling the transportation and handling of chemical substances.
Publication of details of approval
Details of products on the market in other EEA states that have been verified as being identical to ones on the market in the UK for the purposes of commercial parallel imports will be included on the CRD website.
Regulatory Update 08/2008 - Changes to UK control arrangements following ECJ Ruling C-201/06.