S.L. 458.34 Art. 16Information to holder.

(a) When the marketing authorisation is issued it shall be subject to the conditions as specified in the Marketing

Authorisation, the Act and any regulations made thereunder as well as to any conditions that the Licensing Authority may deem necessary, and the holder shall be informed by the Authority of the summary of the product characteristics as approved by it.

(b) The Authority shall:

(i) take all necessary measures to ensure that the information given in the summary is in conformity with that accepted when the marketing authorisation is issued or subsequently;

(ii) make publicly available without delay the marketing authorisation together with the summary of the product characteristics for each medicinal product which it has authorised;

(iii) shall, without delay, make publicly available the marketing authorisation together with the package leaflet, the summary of the product characteristics and any conditions established in accordance with article 23 of the Medicines Act and paragraph (c)

and regulation 17(a) and (b), and together with any deadlines for the fulfilment of those conditions for each medicinal product which they have authorised;;

(iv) shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and pre-clinical tests, the clinical trials, the risk management system and the pharmacovigilance system of the medicinal product concerned. The assessment report shall be updated whenever new information becomes available which is important for the evaluation of the quality, safety or efficacy of the medicinal product concerned. The Authority shall make the assessment report publicly accessible without delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each indication applied for. The public assessment report shall include a summary written in a manner that is understandable to the public. The summary shall contain, in particular, a section relating to the conditions of use of the medicinal product.

(c) In addition to the provisions laid down in regulation 15, a marketing authorisation for a medicinal product may be granted subject to one or more of the following conditions:

(i) to take certain measures for ensuring the safe use of the medicinal product to be included in the risk management system;

(ii) to conduct post-authorisation safety studies;

(iii) to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Title IX of Directive 2001/83/EC as amended;

(iv) any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

(v) the existence of an adequate pharmacovigilance system;

(vi) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Regulation 17 of these regulations, while taking into account the scientific guidance referred to in Article 108a of Directive 2001/83/EC as amended. The marketing authorisation shall lay down deadlines for the fulfilment of these conditions where necessary.