When considering whether to grant a licence, the competent authorities shall take into account in particular the competence and integrity of the applicant.

The licence is to be refused if there are reasonable grounds for doubting the suitability and reliability of the applicant or of the officer responsible for the trade in scheduled substances.

Should the Commission or the applicant refuse to enter into such an agreement, the Commission shall not require the Member State or its appropriate authorities to grant the license or cause it to be granted.

Where, failing amicable agreement, the Commission intends to secure the granting of licenses in one of the cases provided for in Article 17, it shall give notice of its intention to the proprietor of the patent, provisionally protected patent right, utility model or patent application, and shall specify in such notice the name of the applicant for and the scope of the license.

If, when the matter is referred to it under a special agreement, the Arbitration Committee finds that the request from the Commission complies with the provisions of Article 17, it shall give a reasoned decision containing a grant of the license to the applicant and laying down the terms of the license and the, remuneration therefore, to the extent that the parties have not reached agreement on these points.

In considering whether to grant a licence, the competent authorities shall take into account in particular the competence and integrity of the applicant.

When considering whether to grant a licence, the competent authorities shall take into account in particular the competence and integrity of the applicant.

For the purpose of this Annex, GMP includes the system whereby the manufacturer receives the specifications of the product and/or process from the marketing authorisation (MA)/drug identification number (DIN) or licence holder or applicant and ensures the product is made in compliance with the specifications (equivalent to qualified person certification in the EC).