Exemption
If, because of a special situation, a GMP+ participant is unable to comply with (one of) the GMP+ requirements, it is possible to apply for an exemption from GMP+ International. This is possible under Article 11.3 of GMP+ A1 General Regulation of the GMP+ FSA scheme.

A special situation for which an exemption may be applied for may be, for example:

  • a special business operation where it is not possible to comply with the GMP+ requirements
  • the purchase of a special product which can not be obtained in the GMP+ chain
  • a temporary situation where it is not possible to comply with the GMP+ requirements

It is also possible to request an exemption for a feed trial with, for example, a new feed material (which is not on the feed materials risk assessment database list).

Applying for an exemption

An exemption may be applied for by the participant himself, a consultancy firm on behalf of the GMP+ participant or by the certification body of the GMP+ participant. This can be done using the form for this purpose. This form can be found here.

Conditions for exemption

Once the application has been received, GMP+ International will check it against the following criteria:

  • The application must apply to a special product and/or a special situation.
  • Clear reasons must be given by the company applying for the exemption. These must be as clear as possible to obtain a proper insight into the situation. We also need specific information on the product and the supplier. If the application is not clear then it will not be dealt with.
  • It is possible to apply for an exemption for delivery by a supplier who is still in the GMP+ certification process. To obtain an exemption for this, a specific action plan must be provided with a date for an initial audit and an expected certification date. In addition, applications will only be accepted for suppliers where there is no alternative in the GMP+ chain. It is therefore not sensible to submit an application for a product which can be obtained from companies which are already GMP+ certified.
  • No commercial arguments may be used when applying for an exemption. Any agreements which you may have entered into with a particular party whereby your choice of suppliers is limited may not be used as an argument in the application.
  • Exemptions are in theory always of a temporary nature. The GMP+ participant must work towards a solution. In special cases it may be the case that an exemption has a more permanent character.

Gatekeeper protocol

If it is decided by GMP+ International to provide an exemption then the company must comply with the additional requirements in the Gatekeeper protocol. These are extra measures which the company must take in order to guarantee feed safety.

You will find the Gatekeeper protocol here.

 
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