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Where the licensing authority grants an orphan marketing authorisation, the following percentage of the fee otherwise payable under regulation 12(1)(a) in connection with the application for that authorisation shall be refunded, if it has not yet paid, shall be waived
Definitions of different types of marketing authorisation applications: one of the most common questions we are asked is about the definitions of the different types of marketing authorisation applications. We are therefore publishing an extract from the MHRA fees legislation The Medicines (Products for Human Use)(Fees) Regulations 2010 S.I No 551 which defines each of the different types of application: See MHRA fees definitions for information.
If the preliminary analysis of phase 2 test results appears promising, FDA may ask the sponsor to submit a treatment protocol to be reviewed under the procedures and criteria listed in 312.305 and 312.320. Such a treatment protocol, if requested and granted, would normally remain in effect while the complete data necessary for a marketing application are being assembled by the sponsor and reviewed by FDA (unless grounds exist for clinical hold of ongoing protocols, as provided in 312.42(b)(3)(ii)).
All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing and the safety of products following marketing approval apply to drugs covered by this section. This includes the requirements for informed consent (part 50 of this chapter) and institutional review boards (part 56 of this chapter). These safeguards further include the review of animal studies prior to initial human testing ( 312.23), and the monitoring of adverse drug experiences through the requirements of IND safety reports ( 312.32), safety update reports during agency review of a marketing application ( 314.50 of this chapter), and postmarketing adverse reaction reporting ( 314.80 of this chapter).
(3) The application for a marketing authorisation is to be made by the pharmaceutical entrepreneur. For a finished medicinal product manufactured in pharmacies or at other retail dealers using standardized procedures, and distributed to the consumer under a standardized name, the application for a marketing authorisation is to be made by the party responsible for the issue of the master formula. If a finished medicinal product is manufactured for several pharmacies or other retail dealers and is to be distributed to the consumer under their name and under a standardized name, then the manufacturer must apply for the marketing authorisation.
(4) Furthermore, at the request of the competent authority of the Land, the competent higher federal authority decides on the obligation to obtain a marketing authorisation for a specific medicinal product, the obligation to obtain approval for a tissue preparation or a clinical trial, irrespective of an application for a marketing authorisation pursuant to subsection (3) or an application for approval pursuant to section 21a (1) or section 42 (2). The competent Land authority must include a reasoned opinion on the classification of the medicinal product or the clinical trial with the application.
The results pursuant to sentence 1 nos. 1 to 3 are to be substantiated by documentary evidence in such a way that the type, scope and exact time of the tests are clearly evident. The application for a marketing authorisation is to be accompanied by all of the relevant information and documents necessary for the assessment of the medicinal product, whether favourable or unfavourable. This also applies to incomplete or discontinued toxicological or pharmacological tests or clinical trials carried out using the medicinal product in question.
(4) If an application is made for a marketing authorisation in respect of a medicinal product manufactured within the purview of this Act, proof must be furnished that the manufacturer is entitled to manufacture the medicinal product. This does not apply in the case of an application pursuant to section 21 (3) sentence 2.
(5) If an application is made for a marketing authorisation in respect of a medicinal product manufactured outside the purview of this Act, proof is to be furnished that the manufacturer is entitled to manufacture medicinal products in accordance with the legal regulations laid down by the country of manufacture and, in the event that the medicinal product is introduced from a country which is not a Member State of the European Union or a State Party to the Agreement on the European Economic Area, that the importer is in possession of an authorisation to introduce the medicinal product into the territory governed by this Act.
(6) If the medicinal product has already been granted a marketing authorisation in a foreign state, a copy of such authorisation and a copy of the summary of the safety data including the data from the periodic safety update reports, where available, and the reports on suspected adverse reactions are to be included. Where an application for a marketing authorisation has been denied in whole or in part, the details of that decision are to be furnished and the grounds for it explained. Where an application for a marketing authorisation is currently being examined in one or several Member States of the European Union, this is to be stated. Copies of the summaries of the product characteristics and package leaflets approved by the competent authorities of the Member States or, where these documents are not available, the versions of these documents proposed by the applicant in the course of a procedure pursuant to sentence 3, are also to be included. Furthermore, where an application for the recognition of the marketing authorisation of another Member State is submitted, the declarations required under Article 28 of Directive 2001/83/EC are to be submitted along with the other information stipulated therein. Sentence 5 does not apply to medicinal products that have been manufactured according to homeopathic manufacturing procedures.
(7) The application for a marketing authorisation is to be accompanied by the wording of the information that is meant to appear on the container, the outer packaging and the package leaflet as well as the draft of the Summary of Product Characteristics, which is also the expert information pursuant to section 11a (1) sentence 2, where such expert information is stipulated. In the case of medicinal products, the results of evaluations of the package leaflet conducted in collaboration with patient target groups are also to be submitted to the competent higher federal authority. The competent higher federal authority may require the submission of one or more samples or mock-ups of the sales presentation of the medicinal product, including the package leaflets, as well as starting materials, intermediate products and substances that are used in the manufacture or testing of the medicinal products, in a quantity sufficient to conduct the test and in a state suitable to the conduct of said test.
(1) The competent higher federal authority can have the application for a marketing authorisation examined by independent experts to determine whether it is complete and whether the medicinal product has been sufficiently tested according to the current, recognized state of scientific knowledge. Section 25 (6) sentence 5 applies accordingly.
(3) If, on the basis of the final opinion delivered by the expert, the application for a marketing authorisation continues to be incomplete or flawed within the meaning of section 25 (2) sentence 1 no. 2 after the deadline has passed, the marketing authorisation is to be refused. Section 25 (4) and (6) does not apply to the prior examination.
(4) If the competent higher federal authority establishes that an identically worded marketing authorisation application is being reviewed in another EU Member State, it rejects the application and informs the applicant that a procedure pursuant to section 25b applies.
(1) If the applicant is applying for a marketing authorisation or authorisation in more than one EU Member State, the applicant must submit an application based on identical documents in these Member States; this can be worded in English.
(2) If the medicinal product has already been approved or given a marketing authorisation in another EU Member State when the application is submitted, this marketing authorisation is to be recognised on the basis of the assessment report sent by this State, unless there is reason to believe that the authorisation of the medicinal product represents a serious risk to public health. In this case, the competent higher federal authority must proceed pursuant to Article 29 of Directive 2001/83/EC.
(3) If the medicinal product does not have a marketing authorisation at the time of the application, the competent higher federal authority, provided that it is a reference Member State within the meaning of Article 28 of Directive 2001/83/EC, must prepare drafts of the assessment report, the summary of the product characteristics of the medicinal product, the labelling and package leaflet and transmit them to the competent Member States and to the applicant. Section 25 (5) sentence 5 applies accordingly.
(1) The competent higher federal authority must reach its decision on the application for a marketing authorisation within a period of seven months. The decision on the recognition of a marketing authorisation is to be taken within a period of three months following receipt of the assessment report. An assessment report is to be drawn up within a period of three months.
(2) The application for extension is to be supplemented by a report giving details of whether, and to what extent, the criteria by which the medicinal product is assessed have altered over the previous five years. To this end, the marketing authorisation holder must submit to the competent higher federal authority a revised version of the quality, safety and efficacy documents including all amendments made since the marketing authorisation was granted.
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