S.L. 458.34 Art. 5Grantorrenewalof marketing authorisation.

(1) A marketing authorisation may only be granted or renewed if the general conditions applicable to authorisations and the conditions set out under Directive 2001/83/EC on the

Community code relating to medicinal products for human use and subsequent amendments thereto, are fulfilled as follows:

(a) an application for marketing authorisation shall be made to the Licensing Authority which shall refer such application to the Authority for processing;

(b) a marketing authorisation may only be granted to an applicant established in the Community: Provided that by way of derogation from the above, marketing authorisations may be granted until the 31st December 2024, by the Licensing Authority in accordance with the mutual recognition or the decentralised procedure laid down under regulation 22 to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland: Provided further that until the 31st December 2024 the Licensing Authority may extend marketing authorisations already granted prior to the 20th April 2022 to marketing authorisation holders established in parts of the United Kingdom other than Northern Ireland: Provided further that marketing authorisations granted or extended by the Licensing Authority in accordance with the preceding two provisos shall cease to be valid at the latest on the 31st December 2026.

(c) the application shall be accompanied by the following documents and particulars to be submitted in accordance with Annex I:

(i) the name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer;

(ii) the name of the medicinal product;

(iii) qualitative and quantitative particulars of all the constituents of the medicinal product, including the reference to its international non-proprietary name (INN) recommended by the World Health Organisation, where an INN for the medicinal product exists, or a reference to the relevant chemical name;

(iv) evaluation of the potential environmental risks posed by the medicinal product. This impact shall be assessed and, on a case-by-case basis, specific arrangements to limit it shall be envisaged;

(v) a description of the manufacturing method;

(vi) therapeutic indications, contra-indications and adverse reactions;

(vii) posology, pharmaceutical form, method and route of administration and expected shelf life;

(viii) reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of potential risks presented by the medicinal product for the environment;

(ix) description of the control methods employed by the manufacturer;

(x) a written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with regulation 5 of the Good Manufacturing

Practice in respect of Medicinal Products, Active Substances and Investigational Medicinal Products for Human Use Regulations. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice;

(xi) results of pharmaceutical (physico-chemical, biological or microbiological) tests, pre-clinical (toxicological and pharmacological) tests, clinical trials;

(xii) a summary of the applicant’s pharmacovigilance system which shall include the following elements: - proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance, - the Member States in which the qualified person resides and carries out his tasks, - the contact details of the qualified person, - a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC as amended, - a reference to the location where the pharmacovigilance system master file for the medicinal product is kept;

(xiii) the risk management plan describing the risk management system which the applicant will introduce for the medicinal product concerned, together with a summary thereof of the risk management system which the applicant will introduce;

(xiv) a statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of the Clinical Trials

Regulations and of Directive 2001/20/EC of the European Parliament and of the Council of the 4th April, 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products on human use;

(xv) a summary, in accordance with regulation 8, of the product characteristics, a mock-up of the outer packaging, containing the details provided for in the Medicinal Products (Labelling and Packaging) Regulations, and of the immediate packaging of the medicinal product, containing the details provided for in those regulations, together with a package leaflet in accordance with those same regulations;

(xvi) a document showing that the manufacturer is authorised in his own country to produce medicinal products;

(xvii) copies of the following: - any authorisation, obtained in another Member State or in a third country, to place the medicinal product on the market, a summary of the safety data including the data contained in the periodic safety update reports, where available, and suspected adverse reactions reports, together with a list of those Member States in which an application for authorisation submitted in accordance with the provisions of Directive 2001/83/EC, as amended, is under examination,

- the summary of the product characteristics proposed by the applicant in accordance with regulation 8 or approved by the competent authorities of the Member State in accordance with regulation 16 and the package leaflet proposed in accordance with the Medicinal Products (Labelling and Packaging) Regulations, or as approved by the competent authorities of the Member State in accordance with the Medicinal Products (Labelling and Packaging) Regulations, - details of any decision to refuse authorisation, whether in the Community or in a third country, and the reasons for such a decision; (xviii) a copy of any designation of the medicinal product as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, accompanied by a copy of the relevant Agency opinion.

(2) The documents and information concerning the results of the pharmaceutical and pre-clinical tests and the clinical trials referred to in sub-regulation (1)(c)(x) shall be accompanied by detailed summaries in accordance with regulation 9.

(3) The risk management system referred to in sub-regulation (1)(c)(xii) shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

(4) The information in sub-regulation (1) shall be updated where and when appropriate.