Letter of access
A Letter of Access (LoA) is an original document by which the owner of data protected under this Regulation agrees to the use of such data under the specific terms and conditions by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another applicant (Regulation 1107/2009, art.3).
Article 34 of Regulation 1107/2009/EC and article 12 of Directive 98/8/EC and article 20 of Regulation 528/2012 stipulate that Member States shall not make use of information which is ‘protected’ by these articles, unless the data-owner has agreed to it.
This means, that if an applicant wants a national authority to make use of data which are protected, the applicant has to provide evidence that the data-owner has agreed with the national authority using his information for the evaluation of the applicant’s application.
The LoA gives permission to refer to a certain study or set of studies, but it does not transfer the studies nor the studies ownership. The LoA serve as proof of the right to refer. Applicants are exempted from supplying the test and study reports where the Member State to which an application is made has got the test and study reports concerned and the applicants demonstrate that they have been granted access or that any data protection period has expired.
The LoA should be in writing and must:
- be signed. Without signature, the LoA is not legally binding, and should be refused. Only an originally signed LoA is acceptable.
- be signed by a person who is legally competent to perform juristic acts. Someone who is incapacitated or is still a minor, is excluded. The person signing the LoA must have the legal power to represent and bind the data-owner. A proof of binding power is required.
- be recently dated. The LoA should preferably not be older than 12 months; if it is older than 12 months, Ctgb might demand written confirmation that it is still valid.
- clearly state
- the purpose for which it is given Most often this means stating which application (mention product and active substance) the LoA supports.
- the applicant to whom it is given
- to which data it refers to, specified in a way that the competent authority knows with certainty which data are made accessible.
- clearly and without reservations allow the MS to make use of the data. The only acceptable reservation is a limitation of the period of validity in which case it must be clear upfront that the timeframe is matching the time necessary to handle the application. Reservations that make the allowance of access dependent on conditions outside the influence and/or scope of the MS will be refused.
Prospective applicants may want to buy a letter of Access from the data owner to fill in gaps in its dossier. Bellow you will find a LoA template.