The Applicant Guide: Parallel Trade Permit Procedure

Introduction

This guide sets out the arrangements for the granting of Permits under the parallel trade procedure for the placing of plant protection products on the market in UK.

This guidance replaces that issued in August 2008 and is based on the conditions set out in Article 52 of EC Regulation 1107/2009.

Parallel trade

Article 52 (1) states that for the purposes of this procedure parallel trade is the trading of a product which is:

• authorised for placing on the market and use in the country from which it is purchased and is
• identical to one that is already authorised for placing on the market and for use in the UK:

The significance of the Parallel Trade Permit procedure is that an applicant does not need to provide evidence to prove that the product is safe and efficacious, only that it is identical to one which has already been assessed to be safe and efficacious. As a result, the Permit procedure is cheaper, quicker and simpler than for a normal authorisation.

Slightly different rules apply depending whether the product is for the parallel trade of a product for commercial purposes, or whether it is for “own-use” only.

This guide deals with the procedure relating to the commercial parallel Trade Permits. An additional guide deals with the approval for own-use of parallel traded products.

Definition of terms used in this Guide:

• 'EEA state’ means a member state of the EU, or Norway, or Iceland or Liechtenstein;
• ‘reference product’ means a product authorised under PPPR for placing on the market and for use in UK.

General requirements for a Parallel Trade Permit

To obtain a Parallel Trade Permit for a product authorised under EC Regulation 1107/2009 there are two requirements:

• the product to be introduced to the UK market must be identical to a UK reference product; and
• the product must come from an EEA state where it is authorised for placing on the market and for use.

Identicality

The most important condition concerning the Parallel Trade Permit procedure is the identicality of the product to be introduced into the UK to a product already authorised for use in the UK and known for the purposes of this process as the ‘reference product’.

A parallel trade Permit will only be granted provided the product to be traded is shown to be identical to the UK-authorised reference product. The product to be brought in 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 plant health and the environment as the reference product. This will be done by comparing the formulation of the introduced product with that of the reference product including the specification of the active ingredient.

In short, under Article 52 (3) CRD has to be satisfied that the following conditions for establishing identicality are met:

• the formulation of the product to be parallel traded (including the active substances contained in the formulation) have been manufactured by the same company or by an associated undertaking, or under licence in accordance with the same manufacturing process as that which manufactures the formulation of the reference product in the UK. This condition is more familiarly known as sharing ‘common origin’
• the specification and content of the active substances, safeners and synergists are the same and
• the type of formulation (e.g. granule, emulsifiable concentrate) is the same

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 a parallel traded product on the UK market

The product to be brought in to the UK must be packed and labelled in the same or equivalent form in which it is supplied to the end user in the country where it is purchased.

Bulk supplies of material that have not yet been placed on the market for the end user in the country from which they will be purchased are not permitted under this procedure.

Products granted parallel trade Permits under the procedure must be packaged and labelled for the UK market subject to the requirements set out below.

Applications

Applicants should submit their application for authorisation using the application form CRD5 (see also The Applicant Guide) to the Pesticides 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 trade Permit applications will be in accordance with published guidelines operating at the time of the application (see our website).

Article 52 (2) provides that applications shall 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. * Article 52 (2) says that Member State regulatory authorities shall respond within 10 days to a request received from another MS for information necessary to assess whether products are identical.

The fee for parallel trade Permit applications covers the sifting, verification and co‑ordination modules (see Fees Guidance Document).

Information supplied by the applicant

According to Article 52 (4), an application for a parallel trade Permit shall include the following information:

• name and address of the applicant
• the name of the EEA state in which the product is to be purchased, the name of the product and the authorisation number of the product in that state; (to obtain approval to bring in a product from more than one state, this information must be given in relation to each state from which product is to be purchased;
• 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 product to be brought in share common origin,
• the name and address of the authorisation holder in the Member State of origin;
• the name to be given to the product when placed on the UK Market
• a draft of the label to be adhered to the product when placed on the UK market.

Much of this information is required in the application form CRD5.

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 original product and the reference product
• other useful information in your possession, such as:
• content of active ingredient in the parallel traded 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, under Article 52 (4) (h) HSE may also require applicants to submit a sample of the product they intend to place on the UK market.

You may also submit any other evidence to show that in your opinion the product to be brought in is identical to a UK reference product.

Guidance on labels and labelling:

• Note that CRD will not check your draft label but will require that the parallel traded product is labelled in accordance with the UK reference product.
• If a label check is required then you should request this in your covering letter and submit 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. Please note that there will be an additional fee for such a label check.
• the instructions on the label of the parallel product 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 paralleled product and the label on the reference product.

Re-packaging

In accordance with Article 52 (3) (c), the form, material and size of the packaging of the parallel traded product must be the same as that for the reference product. Repackaging may be permitted provided 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 to 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 trade Permit applications. This would be outside the scope of the object of the scheme which is to enable the trading 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. It will no longer be considered to be a parallel trade Permit application.

Approval

Under Article 52 (1) of Regulation 1107/2009, parallel traded products will not receive an Authorisation as such but will be granted a ‘Permit’. When an application reaches a successful conclusion the parallel traded product will receive a MAPP number and its details will be included on the databases available on the CRD website.

The Permit and its date of expiry will be linked to the reference product so that:

• Article 52 (5) provides that where the reference product holds a full authorisation for certain uses, the parallel traded product will be given a full Permit for any or all of those uses; and
• Article 52 (6) provides that where the reference product holds a time limited authorisation for certain uses, for example because there are outstanding data requirements for continuing authorisation, the paralleled product will only be given a Permit with the same shortened expiry date for those uses.

A parallel trade Permit 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

Conditions governing named country/countries of purchase

The Permit will specify the country or countries from which the product may be purchased, and its authorisation number in that member state.

Length of Permit

A parallel Permit will be granted for up to a maximum of 10 years (subject to review) dependent upon the continued authorisation of the original product in the country of origin.

Any subsequent safety issues that arise, e.g. a review of the active substance leading to revocation of products containing that active, will result in the revocation of the parallel Permit (see All Approval Holder Letter 27/2002).

For continuation of the Permit beyond the specified expiry date, an application for a new Permit will be required.

A general point that should be noted is that where a reference product is revoked and the parallel Permit is allowed to continue, the latter shall expire by the date on which the authorisation of the reference product would normally have expired.

Post Approval Requirements

When a Permit is granted, the 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 into the UK, 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 bring in to the UK. CRD may request these details at any time to ensure that the formulation of the product subject to the Parallel Trade Permit 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 at the time the permit is issued, the applicant must notify CRD when they wish to start selling it.

In order to ensure that parallel trade products meet the conditions established in the Permit, and in particular the criteria regarding identicality, CRD may require the provision of any information it considers necessary at any time after the parallel trade Permit has been given for a product.

As is the case for all other authorised products, CRD will routinely carry out full chemical analysis on a sample of parallel traded products to check that they meet international Food and Agriculture Organisation (FAO ) specifications. The Permit holder will only be contacted in the event of a problem being identified from the analysis results.

Where CRD establishes that any parallel traded product fails to conform to any condition of the Permit, the Ministers may revoke or suspend the Permit, and order the re-exportation of the product already brought into the UK.

Revocation of permits

A parallel trade Permit will be revoked if:

• the parallel traded product ceases to be authorised in the member state of origin because of safety or efficacy reasons (Article 52 (8) also refers).
• the reference product authorisation 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 authorisation holder or marketing company name.

Refusal of parallel trade Permit application

Where identicality is not established to the satisfaction of CRD during evaluation, a Permit application will be refused, and as far as commercial confidentiality considerations will allow, the reason for refusal will be given.

If an applicant believes that details held by the UK or the exporting Member State are not up to date, they may request CRD to approach the authorisation holder to confirm the formulations of the products concerned. Such an appeal would be outside the terms of Article 52 and would be subject to an additional fee.

Where such an appeal is unsuccessful and in all cases where a Parallel Trade Permit is refused, it is open to the applicant to apply for an authorisation supported by an appropriate data package via a different application stream. It will not be considered to be a Parallel Trade Permit application (Article 52 (9) refers).

A Permit application will be refused where the reference product authorisation has been withdrawn for commercial reasons because the active substance in the product is under review.

Additional considerations

Batch variation

Post approval, the parallel traded 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 Permit holders 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 the parallel Permit scheme will be included on the CRD website.