General principles – registration procedures for placing on the market of medicinal products for human use (Directive_2001/83/EC; Regulation_EEC/2309/93; 2003/63/EC; 2004/24/EC;2004/27/EC; Regulation_EC/726/2004 )
Human blood and blood components products- standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components ( Directive 2002/98/EC )
Traditional herbal medicinal products (2004/24/EC- as amended Directive 2001/83/EC)
Clinical trials - good clinical practice in the conduct of clinical trials on medicinal products for human use ( Directive_2001/20/EC ).
Good clinical practice for authorization of the manufacturing or import of medicinal products for human use and for “investigational medicinal products” ( Directive 2003/94/EC ; Directive 2005/28/EC )
Pricing of medicinal products for human use- transparency measures and their inclusion within the scope of the national health insurance system ( Directive 89/105/EEC )
Fees payable to the European Medicines Agency ( EC/1905/2005)
Suspected unexpected adverse reactions which are not serious- principles for reporting (EC/540/95 )
Transfer of a marketing authorizations from a Marketing Authorization Holder to another Regulation_EC/2141/96
Variations to the terms of a marketing authorization for medicinal products for human use (EC/1084/2003;EC/1085/2003)
Conditional marketing authorization ( Regulation EC/507/2006 )
Medicinal products for pediatric use (Regulation 1901/2006;EC/1902/2006)
Coloring matters which may be added to medicinal products for human use (EC/78/25)
Contained use of genetically modified ( 90/219/EEC;98/81/EC;2001/18/EEC
Supplementary protection certificate for medicinal products (EEC/1768/92)
Parallel imports of proprietary medicinal product for which marketing authorizations have already been granted (6/5/1982; COM/2003/839)
Directive 2001/83/EC (amended by Directives 2002/98/EC, 2004/24/EC, 2004/27/EC, 2003/63/EC)- is the first European Community regarding to manufactured, distribution and administered of the medicinal products for human use, so the public health will be assured.
Article 1 - terms definitions for understanding this Directive and the principles of legislation for medicinal products for human use (medicinal product, substance, immunological medicinal product, homeopathic medicinal product, radiopharmaceutical, radionuclide generator, kit, radionuclide precursor, medicinal products derived from human blood or human plasma, adverse reaction, serious adverse reaction, unexpected adverse reaction ,periodic safety update report, post-authorization safety study, abuse of medicinal products, wholesale distribution of medicinal products, public service obligation, representative of the marketing authorization holder, medicinal prescription, name of the medicinal products, common name, strength of the medicinal product, immediate packaging, outer packaging, labeling, package leaflet, risks related to use of the medicinal products, risk- benefit balance, traditional herbal medicinal products, herbal medicinal products, herbal substances, herbal preparations)
Article 5 - a Member State may exclude from the provision of this Directive medicinal products supplied in response to a bona fide unsolicited order or in response to the suspected or confirmed spread of pathogenic agent, toxins, chemical agents, or nuclear radiation any of which could cause harm
Article 6 - no medicinal product may be place on the market unless a marketing authorization has been issued in accordance with this Directive
Article 8 - in order to obtained an authorization to place a medicinal product on the market an application shall be made to the competent authority of the Member State concerned; this application shall be accompanied by the particulars and documents describes in this articles; a marketing authorization may only be granted to an applicant established in the Community
Article 10 - the applicant shall not be required to provide the results of the pre-clinical tests and the clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorized for not less than eight years in a Member State or in the Community; this generic product shall not be place on the market until ten years has elapsed from initial authorization of the reference product. This article contains the definitions for generic medicinal product and the reference product and the cases when the applicant shall provided the result of the appropriate pre-clinical tests
and clinical trials
Article 11 - described what information the summary of product characteristic shall contained
Article 14 - conditions for homeopathic medicinal products to grant a marketing authorization through a simplified registration procedure
Article 16 - homeopathic medicinal products other than those referred to in article 14 shall be authorized and labeled in accordance with this Directive
Article 16a, c – conditions for traditional herbal medicinal product to grant a marketing authorization through a simplified registration procedure
Article 16 h - The Committee for Herbal Medicinal Products as part of the Agency- competences and responsibilities
Article 17 - Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorization for medicinal product is completed within 210 days after the submission of a valid application
Article 21- the competent authorities shall draw up an assessment report of the medicinal product concerned which shall be updated and shall be make publicly accessible
Article 24 - a marketing authorization shall be valid for 5 years and may be renewed after 5 years on the basis of the re-evaluation of the risk- benefit balance by the competent authority of the authorizing Member State; any authorization which within three years of its granting is not followed by the actual placing on the market of the authorized product in the authorizing Member State shall cease to be valid.
Article 27 - organization of the Coordination Group, accompanied by experts for the examination of any question related to mutual recognition and decentralized procedure
Article 28 - with a view to the granting of a marketing authorization for a medicinal product in more than one Member State , an applicant shall submit an application based on an identical dossier in these Member State . Reference Member State shall prepare an assessment report on the medicinal product which together with the approved summary of product characteristics, labeling and package leaflet shall be sent to the concerned Member State and to the applicant.
Articles 30-34 - the steps that will be followed when divergent opinion between Member States regarding to granting an authorization to place on the market –set up of the Committee for Medicinal Products for Human use
Article 41, 46 - conditions for granting of the manufacturing authorization for medicinal products for human use
Article 43 - manufacturing authorization shall be released within maximum 90 days from the day on which the competent authority receives the application
Articles 49-52 - the qualified persons working in production- responsibilities and conditions
Articles 54, 56a - information that shall be appear on the outer packaging or when this is not exist on the on the immediate packaging (name of the medicinal product should be in Braille)
Article 55 - information that shall be appear on theblister pack or on small immediate packaging units
Article 59 - the package leaflet shall be drawn up in accordance with the summary of the product characteristic
Article 63.3 - when the product is not intended to be delivered directly to the patient, the competent authorities may grant an exemption to the obligation that certain particulars should appear on the labeling and in the package leaflet
Article 69 - information that shall be appear on the labeling and the package insert for the homeopathic medicinal product
Article 70 - when an marketing authorization is granted the competent authorities shall specify the classification of the medicinal product
Article 71 - the conditions when an certain medicinal product is classified as article 70 said
Article 74a - where a change of classification of a medicinal product has been authorized on the basis of significant of pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those test or trials when examining an application by another applicant for or holder of marketing authorization for a change of classification of the same substance for one year after the initial change was authorized
Article 76.3 - any distributor not being the marketing authorization holder, who imports a product from another Member State , shall notify the marketing authorization holder and the competent authority of the Member State to which the product will be imported of his intention to import it
Articles 79,80 - conditions for being an authorized distributor
Article 83 - more stringent requirement shall laid down by Member States for certain medicinal products ( narcotics and psychotropic, medicinal products derived from blood, immunological medicinal products, radiopharmaceuticals)
Articles 86-90 - what advertising for medicinal products means, rules which Member States shall respect regarding the advertising to the public
Articles 91-98 - advertising to qualified persons
Article 101 - the Member States shall take all appropriate measures to encourage doctors and other healthcare professionals to report suspected adverse reactions to the competent authorities
Article 103- the Marketing Authorization Holder shall have permanently at his disposal an appropriately qualified person responsible for pharmacovigilance
Article 104.6 - Periodic Safety Update Report shall be submitted immediately upon request or at least every six months during the first two years following the initial placing on the market and once a year for the following two years. Thereafter, the report shall be submitted at three yearly intervals or immediately upon request.
Article 107.2 - where urgent action to protect public health is necessary, the Member State concerned may suspend the marketing authorization of a medicinal product, provided that the Agency, the Commission and the other Member States are informed no later than the following working day
Article 111 - the Competent Authorities may carry out unannounced inspections at the premises of manufacturers of active substance used as starting materials or at the premises of marketing authorization holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice
Article 114 - for certain product a Member State may require the holder of marketing authorization to submit samples from each batch for examination by an Official Medicines Control Laboratory before release on to the market; Member State shall ensure that any such examination is completed within 60 days of the receipt of the samples
Article 117 - conditions for withdrawal from the market into a Member State
Article 122 - between Member States and between Member States and the Agency must exist a continuous communication regarding revocation, withdrawal or variation or inspection for an medicinal product
Article 126a - in the absence of a marketing authorization or of a pending application for a medicinal product authorized in another Member State, a Member State may, for justified public health reasons authorize the placing of the market the of the said medicinal product
Annex I- analytical, pharmacological and clinical standards for medicinal products testing
Regulation EC/ 726/2004 – this regulation laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicine Agency-EMEA
Article 2 - the holder of a marketing authorization must be established in Community. He is responsible for placing on the market of the medicinal products whether he does it himself or via one or more persons designated to that effect
Article 3 - in the annex there are medicinal products which must be authorized through this Community procedure. Any medicinal product not appearing in the annex may be granted a marketing authorization by the Community if the medicinal product contains a new active substance or the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization is in the interests of patients and animal health a Community level.
A generic medicinal product of a reference medicinal product authorized by the Community may be authorized by the competent authorities of a Member State in accordance with Directive 2001/83/EC under the conditions described at points a), b), c) from this regulation; Generic medicinal product is authorized under the same name in all the Member States where the application has been made; all linguistic version of the INN (International non-proprietary name-INN ) shall be considered to be the same name
Article 5 - Committee for Medicinal Products for Human Use-CMPH is responsible for drawing up the opinion of the Agency on any matter concerning the admissibility of the files submitted in accordance with the centralized procedure, the granting, variations, suspension or revocation of an authorization to place a medicinal product on the market pharmacovigilance. CMPH shall also formulate an opinion whenever there is disagreement in the evaluation of medicinal products through the mutual recognition procedure
Article 6 - the Agency shall ensure that the opinion of the Committee of the Medicinal Products for Human Use is given within 210 days after receipt a valid application
Article 10 - within 15 days after receipt of the opinion from CMPH , the Commission shall prepare a draft of the decision to be taken in respect of the application
Article 12 - in cases where the marketing authorization shall be refused, the Commission shall be made publicly the reasons for that
Article 13 - Community authorized medicinal products shall be entered in the Community Register of Medicinal Product and shall be given a number, which shall appear on the packaging.
After a marketing authorization has been granted, the holder of the authorization shall inform the Agency of the dates of actual marketing of the medicinal product on the market or if the product ceases to be placed on the market either temporarily or permanently; such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product.
Upon request by the Agency, particularly in the context of pharmacovigilance, the MAH shall provide the Agency with all data relating to the volume of sales and prescriptions of the medicinal product at Community level
Article 14 - Any authorization which is not followed by the actual placing on the Community market for three consecutive years, that authorization shall ceased to be valid.
For certain specific obligations, an authorization may be granted for one year and shall be renewable annually.
In certain circumstances, when an medicinal products is of major interest for the public health, the timelines for accordance of an authorization may be reduced to 150 days.
Article 15 - The granting of authorization shall not affect the civil and criminal liability of the manufacturer or of the holder of the marketing authorization pursuant to the applicable national law in Member States
Article 20 - Where the supervisory authorities or the competent authorities of any other Member States are of the opinion that the manufacturer or the importer established within the Community is not longer fulfilling the obligation laid down in this Regulation, the Commission shall request the opinion of the Agency within a six months time-limit for provided necessary measures. Where urgent action is essential, medicinal product shall be suspended immediately and the Agency shall be informed in the next working day about this decision.
Article 22 - Every suspected adverse reaction shall be brought to the attention of the Agency and the CMPH shall take all necessary measures that shall be made publicly accessible
Article 23 - The MAH shall have at his disposal an qualified person responsible for pharmacovigilance which must implement a pharmacovigilance system as to all adverse reactions shall be collected, collated and evaluated at a single point within the Community.
Article 24 - The MAH shall ensure that all suspected serious adverse reactions to a medicinal product authorized in accordance with this Regulation occurring within the Community which a healthcare professional brings to his attention are recorded and reported promptly to Member States in the territory of which the incident occurred and the Agency, no later than 15 days following receipt of the information.
Periodic Safety Update Reports shall be accompanied by a scientific evaluation of the risk –benefit balance of the medicinal product
Articles 55-63 - established of the European Medicinal Agency (the Agency); roles and responsibilities
Article 82 - for a medicinal product covered by a single authorization shall be used one or more commercial designs
Article 83 - Member States may make a medicinal product for human use available for “compassionate use” for patients with chronically and seriously debilitating disease or whose disease is considered to be life-threatening and who can not be treated by authorized medicinal products; the medicinal products concerned must either be the subject of an application for a marketing authorization in accordance with this Regulation or must be undergoing clinical trials
Directive 2002/98/EC - setting standards of quality and safety for collection, testing, processing and distribution of human blood and blood components
Article 1 - this directive shall apply to the collection and testing of human blood and blood components whatever their intended purpose and processing, storing and distribution when intended for transfusion; shall not apply to blood stem cells
Article 4 - Member States may introduce more stringent restrictions protective measures in its territory to ensure a high level of health protection
Article 5 - activities relating to the collection, testing, processing, storing and distribution of human blood and blood components are undertaken only by the blood establishments which have been designated, accredited or licensed authorized for that purpose
Article 14 - Member States shall take all necessary measures in order to ensure that human blood and blood components collected, tested, processed, stored, released and/or distributed on their territory can be traced from donor to recipient and vice versa
Article 15 - any serious adverse events and adverse reactions related to the collection, testing, processing, storing and distribution of human blood and blood components shall notify to the Competent Authorities
Article 19 - eligibility of the donor shall be carried out by examination and assessing by a qualified healthcare professional
Article 21 -blood establishment and Member States shall ensure that each donation and import of human blood and blood components is tested in accordance with requirements listed in annex IV
Article 24 - Member States should take all necessary measures to ensure data confidentiality
Article 26 - - Member States shall sent to the Commission at every three years a report on the activities undertaken in respect of this Directive
Article 29 - technical requirements for collection, testing, processing, storing and distribution of human blood and blood components
Annex I- information to be provided by blood establishment to the Competent Authority for the purposes of designation, authorization, accreditation or licensing in accordance with article 5
Annex II- report of the blood establishment's preceding year's
Annex III- labeling requirements
Annex IV-basic testing requirements for whole blood and plasma donations
Directive 2001/20/EC - for implementation of good clinical practice
Article 2 - terms used in clinical trials
Article 3 - if Member States have more comprehensive rules for protection of clinical trials subjects, these should be considered if these are consistent with procedures and timescale therein. Member States shall adopt detailed rules to protect from abuse individuals who are incapable of giving their informed consent. A clinical trial may be undertaken only if particular rules that protect subjects are in place.
Article 4 - Clinical trials on minors- relevant restrictions
Article 5 - Clinical trials on incapacitated adults not able to give inform legal consent
Article 6 - Ethics Committee shall preparing an opinion within 60 days before a clinical trial may be put in practice
Article 7 - in the case of multi-centre clinical trials carried out in more than one Member State simultaneously a single opinion shall be given for each Member State concerned by the clinical trial
Article 9.6 - no clinical trial can be carried out which result in modification to the subject's germ line genetic identity
Article 12 - in certain situation a clinical trial may be suspended or prohibited by a Member State
Article 13 - Member States shall ensure that the manufacturer and the importer holds an authorization for an investigational product to begin an clinical trial; if not, the applicant or the holder of marketing authorization must have at least European Council ( 1999/468/EC-art. 5,7) agreement.
Article 14 - labeling of the investigational product
Article 15 - To verify compliance with the provisions on good clinical practice and manufacturing practice, Member States shall appoint inspectors to inspect the sites concerned by any clinical trial
15.5 Ethics Committee shall keep all documents regarding to a clinical trial for at least 3 years after the study is completed
Article 16- the sponsor of a clinical trial shall keep evidence of all adverse events reported by investigator and shall submitted if requested to Member State where the study is performed
Article 17 - unexpected adverse reactions must be reported by the sponsor in maximum 7 days to Member State and to the Ethic Committee
Article 1 - This Directive lays down the principle and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacturing requires the authorization referred to in Directive 2001/83/EC and in respect of the investigational products for human use whose manufacture requires the authorization referred to in Directive 2001/230/EC.
Article 7 - At each manufacturing site, the manufacturer shall have at his disposal appropriately qualified personnel which attending initial and on going training in order to achieved quality assurance objectives and good manufacturing practice
Article 9 - For a medicinal product, the batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates; for an investigational medicinal product the batch documentation shall be retained for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used.
Article 11 - For medicinal products any critical modification of an manufacturing process shall be validated; for investigational products any phases of the manufacture process shall be validated or at least critical phases, such as sterilization.
Article 13 - for a medicinal product or an investigational medicinal product the manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling it, promptly and at any time from distribution network
Article 1 - This directive lays down the principle for good clinical practice, requirements for manufacturer authorization and guidelines for documentation of a new clinical study in cases of an investigational product
Article 2 - the rights, safety and well being of the trial subjects shall prevail over the interest of science and society
Article 7 - the sponsor is responsible for ensuring that the conduct of a trials and the final data generating by those trials comply with Directive 2001/20/Ec as well as this Directive.
Article 8.2 - if the investigational medicinal product has a marketing authorization, the Summary of product Characteristic may be used instead of the investigator's brochures
8.3 - the investigator's brochure shall be validated and updated by the sponsor at least once a year
Article 9.2 - authorization for reconstitution prior to use or packaging of an investigational medicinal product is not required if those process are carried out exclusively in hospitals, health centers, or clinics by pharmacists or other person legally authorized in the Member States
Article 10 - documents providing to competent authorities in order to obtain an authorization for manufacture or import of an investigational medicinal product
Article 13 - the holder of an authorization shall comply with requirements as regards manufacture and quality control
Article 17 - the sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion
Articles 21-28 - requirements for inspectors and inspections arisen at the beginning or during the development of a clinical study
Article 29 - in order to harmonies the conduct of inspections by the competent authorities of different Member States, guidance documents containing the common provision on the conduct of those inspections shall be published by the Commission after consultation with the Member States
Directive 89/105/EEC – is relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems; this Directive shall not imposed upon the national policies for established the pricing but upon the transparency of those policies.
Article 10 - a Committee called “The Consultative Committee” for the implementation of Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems shall be set up and attached to the Commission; the Committee shall consist of one representative from each Member State
Article 11 - Member States shall communicate to the Commission the text of any law, regulations or administrative provisions relating to the pricing of medicinal product, the profitability of manufacturers of medicinal products and the coverage of medicinal products by the national health insurance system
Regulation EEC/2309/93 - referring to Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for Evaluation of Medicinal Product
Article 5 - The Committee for Proprietary Medicinal Product established by article 8 of Directive 75/319/EEC shall be responsible for formulating the opinion of the Agency on any question concerning the admissibility of the file submitted in accordance with centralized procedure, the granting, variation, suspension or withdrawal of an authorization to place an medicinal product on the market
Article 6 - The Committee will given an opinion within 210 days from receiving an valid application
Article 12 - A Community marketing authorization shall be valid throughout the Community
12.4 - upon request from any interested person the Agency shall make available the assessment report of a medicinal product and the reasons for granting an authorization at Community level (after deletion of any information of commercially confidentially nature)
Article 13.1 - authorization shall be valid for five years and shall be renewable for five years period on application by the holder at least three months before the expiry date
13.2 - in exceptional circumstances and following consultation with the applicant , an authorization may be granted subject to specific obligation, to be renewed annually by the Agency ( part 4G of the annex to Directive 75/318/EEC )
13.4 - period of protection for such medicinal product (art.4 of directive 65/65/EEC) is ten year
Article 16 - in the case of medicinal products manufactured within the Community, the supervisory authority shall be the competent authority of the Member State which have granted the manufacturing authorization provided for in Article 16 of Directive 75/319/EEC
In the case of medicinal products imported from third country the supervisory authorities shall be the competent authority of the Member State in which the quality control referred to in article 22-(1)(b) are carried out
Article 18 - where the supervisory authority or the competent authorities of any other Member State are of the opinion that the manufacturer or importer from third country is not longer fulfilling the obligation laid down in chapter IV of Directive 75/319/EEC, they shall forthwith inform the Committee and the Commission
Article 21 - the person responsible for the placing on the market of a medicnal product authorized by the Community shall permanently at his disposal an appropriately qualified person responsible for pharmacovigilance
Articles 49-56 - The European Agency for the Evaluation of Medicinal Product- component part and tasks
Article 58 - the structure and the amount of fees shall be establish by the Council on a proposal from the Commission following consultation with pharmaceutical industry at Community level
Article 59 - The Agency shall have legal personality
Regulation EC/2141/96 - concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation EC/2309/93, except of the situation covered by point 3 of Annex I to commission Regulation EC/542/95
Article 2 - “transfer of a marketing authorization” means the procedure for changing the addressee of the marketing authorization, the new holder not being the previous holder
Article 5 - The Agency's opinion can only be unfavorable if the documents submitted in support of the application are incomplete or the person to whom the transfer shall be granted is not establish in the Community
Regulation EC/141/2000 - referring to orphan medicinal products
Article 1 - the purpose of this Regulation is to lay down a community procedure for the designation of medicinal products as orphan medicinal product and to provide incentives for the research, development, and placing on the market of designated orphan medicinal products
Article 3 - criteria for designation of orphan medicinal product
Article 4 - Commitee for orphan medicinal product
Article 5 - in order to obtain the designation of a medicinal product as orphan, the sponsor shall submit an application to the Agency at any stage of the development of the medicinal product before the application for marketing authorization is made
Article 7.1 - the person responsible for placing on the market an orphan medicinal product may request that authorization to place the medicinal product on the market be granted by the Community in accordance with the provision of regulation EC/2309/93 without having to justify that the medicinal product qualifies under part B of the Annex to that Regulation
7.3- the marketing authorization granted for an orphan medicinal product shall cover only those therapeutic indications which fulfill the criteria set out in article 3; this is without prejudice to the possibility of applying for a separate marketing authorization for other indications outside the scope of this Regulation
Article 8 - where a marketing authorization in respect of an orphan medicinal product is granted pursuant to regulation EEC/2309/93 or where all the member State have granted marketing authorization in accordance with the procedure laid down in Directive 75/319, the Community and the member States shall not, for a period of ten years accept another application for a marketing authorization or grant a marketing authorization or accept an application to extent an existing marketing authorization, for the same therapeutic indication, in respect of a similar medicinal product
8.2 - that period may be reduced to six years on the basis on available evidence that the product is sufficiently profitable
8.3 - in certain circumstances a marketing authorization may be granted, for the same therapeutic indication to a similar medicinal product
Regulation EC/847/2000 - criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts “similar medicinal product” and “clinical superiority”
Article 1- documents necessary for consider a medicinal product as “orphan”
Article 3 - definitions
Regulation EC/507/2006 - conditional marketing autorisation
Article 2 - this regulation shall apply to medicinal product that fall under article 3(1) and (2) of EC/724/2000 and belong to one of the following categories:
Medicinal products which aim at the treatment, the prevention or the medical diagnosis of serious debilitating diseases or life-threatening diseases
Medicinal products to be used in emergency situation duly recognized by the World Health Organization or by the Community in the framework of the decision 2119/98/EC
Medicinal products designated as orphan medicinal product in accordance with regulation EC 141/2000
Article 3 - a request for a conditional marketing authorization may be presented by the applicant together with an application in accordance with article 6 of regulation EC/726/2004
Article 4 - a conditional marketing authorization may be granted if the Committee (CMPH) finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied all the other requirement are met
Article 5 - by way of specific obligation the holder of a conditional marketing authorization shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data referred to in article 4(1)
Article 6 - authorization may be renewed annually with 6 months before the expiry date
6.4 - once renewed, an authorization shall remain valid until a decision is adopted by the CMPH in accordance with article 10 of EC/726/2004
Article 7 - when the specific obligations laid down in accordance with article 5 has been fulfilled a conditional marketing authorization shall be granted according to article 14 of EC/724/2004
Article 9- the periodic safety update report shall be submitted to the Agency and Member States immediately upon request or at least every six months following the granting or renewal of a conditional marketing authorization
Article 10 - a potential applicant may request the advice of the Agency on whether a specific medicinal product falls within one of the categories set out in article 2
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