Legal provisions of COM(2011)633 - Amendment of Directive 2001/83/EC, as regards information to the general public on medicinal products subject to medical prescription and as regards pharmacovigilance - Main contents
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| dossier | COM(2011)633 - Amendment of Directive 2001/83/EC, as regards information to the general public on medicinal products subject to medical ... |
|---|---|
| document | COM(2011)633  |
| date | October 11, 2011 |
Article 1
(1) In Article 23a, the second subparagraph is replaced by the following:
"The holder shall also notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The holder shall inform the competent authorities of the reasons for such action in accordance with Article 123."
(2) Article 31 is replaced by the following:
"Article 31
1. The Member States, the Commission, the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Union are involved, refer the matter to the Committee for application of the procedure laid down in Articles 32, 33 and 34 before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary.Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the matter shall be referred to the Pharmacovigilance Risk Assessment Committee and Article 107j(2) may be applied. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the coordination group, as appropriate, and the procedure laid down in Article 107k shall apply.
However, where one of the criteria listed in Article 107i(1) is met , the procedure laid down in Articles 107i to 107k shall apply.
2. Where the referral to the Committee concerns a range of medicinal products or a therapeutic class, the Agency may limit the procedure to certain specific parts of the authorisation.
In that event, Article 35 shall apply to those medicinal products only if they were covered by the authorisation procedures referred to in this Chapter.
Where the scope of the procedure initiated under this Article concerns a range of medicinal products or therapeutic class, medicinal products authorised in accordance with Regulation (EC) No 726/2004 which belong to that range or class shall also be included in the procedure."
(3) In Article 34(3), the following subparagraph is added:
"Where the scope of the procedure includes medicinal products authorised in accordance with Regulation (EC) No 726/2004 pursuant to the third subparagraph of Article 31(2) of this Directive, the Commission shall where necessary adopt decisions to vary, suspend, revoke or refuse renewal of the marketing authorisations concerned".
(4) Article 86 is replaced by the following:
"Article 86
1. For the purposes of this Title, advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products by the marketing authorisation holder directly or indirectly through a third party acting on his behalf or following his instructions; it shall include in particular:(a) the advertising of medicinal products to the general public,
(b) advertising of medicinal products to persons qualified to prescribe or supply them,
(c) visits by medical sales representatives to persons qualified to prescribe medicinal products,
(d) the supply of samples,
(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,
(f) sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,
(g) sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.
Any reference to marketing authorisation holders in this Title shall include marketing authorisation holders and third parties acting on their behalf or following their instructions.
:
2. The following are not covered by this Title
(a) the labelling and the accompanying package leaflets, which are subject to the provisions of Title V;
(b) information relating to human health or diseases, provided that there is no reference, even indirect, to individual medicinal products;
(c) information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which shall comply with the provisions of Title VIIIa.
(d) information by the marketing authorisation holder to investors and employees on business developments, provided they are not used to promote medicinal products. If announcements concern individual medicinal products, the provisions of Title VIIIa shall apply. "
(5) Article 88(4) is replaced by the following:
"4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
Such vaccination campaigns shall be approved by the competent authorities of the Member States only if it is ensured that objective, non-biased information is provided by the industry in the framework of the campaign regarding the efficacy, the adverse reactions and contra-indications of the vaccine";
(6) The heading “TITLE VIIIa “Information and advertising” is deleted;
(7) Article 88a is deleted;
(8) The following Title VIIIa is inserted after Article 100:
“Title VIIIa – Information to the general public on medicinal products subject to medical prescription
Article 100a
1. This Title shall apply to information to the general public or members thereof on authorised medicinal products subject to medical prescription, which is made available by marketing authorisation holders.Any reference to marketing authorisation holders in this Title shall include marketing authorisation holders and third parties acting on their behalf or following their instructions.
Information which complies with the provisions of this Title shall not be considered advertising for the purposes of the application of Title VIII.
2. This Title shall not cover the following:
(a) public announcements by marketing authorisation holders relating to information on pharmacovigilance concerns, which are subject to Article 106a;
(b) information relating to human health or diseases, provided that there is no reference, even indirect, to individual medicinal products;
(c) material provided by the marketing authorisation holder to healthcare professionals for their own use;.
(d) information by marketing authorisation holders to investors and employees on business developments, provided that the information does not concern individual medicinal products and is not used to promote medicinal products.
3. Without prejudice to paragraph 1, when information is made available to the public by persons other than the marketing authorisation holder, any financial or other benefits from marketing authorisation holders shall be declared by the person making the information available.
Article 100b
1. The following information on authorised medicinal products subject to medical prescription shall be made available by the marketing authorisation holder to the general public or members thereof:(a) the most recent summary of the product characteristics as approved by the competent authorities;
(b) the most recent labelling and package leaflet as approved by the competent authorities;
(c) the most recent publicly accessible version of the assessment report as drawn up by the competent authorities.
2. The following information on authorised medicinal products subject to medical prescription may be made available by the marketing authorisation holder to the general public or members thereof:
(a) information on the environmental impact of the medicinal product further to the information on the disposal and collection system contained in the documents referred to in paragraph 1,
(b) information on prices;
( c) information on pack changes
(d) information on the instructions for use of the medicinal product, further to the information contained in the documents referred to in paragraph 1;
(e) information on the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned;
(f) a summary of frequently submitted requests for information pursuant to Article 100c(c), and the answers to such requests;
(g) other types of information approved by competent authorities that are relevant to support the proper use of the medicinal product.
The information referred to in point (d) of the first paragraph may be completed, where necessary, with still or moving images of a technical nature demonstrating the proper way of using the product.
Article 100c
Information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television, radio or printed media. It shall only be made available through the following channels:(a) printed materials about a medicinal product prepared by the marketing authorisation holder made available to the general public or member thereof on request or through healthcare professionals;
(b) internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
(c) written answers to specific requests for information about a medicinal product of a member of the general public.
Article 100d
1. The content and presentation of information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to the general public or members thereof shall fulfil the following conditions:(a) it shall be objective and unbiased; in this regard, if the information refers to the benefits of a medicinal product, its risks shall also be stated;
(b) it shall be patient-oriented to adequately meet the needs and expectations of patients;
(c) it shall be based on evidence, be verifiable and include a statement on the level of evidence;
(d) it shall be up-to-date and include the date of publication or last revision of the information;
(e) it shall be reliable, factually correct and not misleading;
(f) it shall be understandable and legible for the general public or members thereof;
(g) it shall clearly state the source of the information indicating its author and giving references to any documentation that the information is based on;
(h) it shall not contradict the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities.
2. Any information shall include:
(a) a statement that the medicinal product concerned is available on prescription only and that instructions for use appear on the package leaflet or on the outer packaging, as the case may be;
(b) a statement indicating that the information is intended to support, not to replace, the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification on the information provided or further information;
(c) a statement indicating that the information is made available by or on behalf of or following instructions of a named marketing authorisation holder;
(d) a postal address or e-mail address allowing members of the general public to send comments to, or requests for further information from, the marketing authorisation holder;
(e) a postal address or e-mail address allowing members of the general public to contact the competent authorities which have authorised the medicinal product;
(f) the text of the most recent package leaflet or an indication as to where that text may be found.
3. The information shall not include:
(a) comparisons between medicinal products;
(b) any of the material referred to in Article 90.
4. In order to ensure the quality of information made available to the general public and members thereof, the Commission shall adopt, by means of implementing acts, the measures necessary for the implementation of paragraphs 1, 2 and 3. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 121(2).
Article 100e
1. Member States shall ensure that marketing authorisation holders' Internet websites on which information on medicinal products subject to medical prescription are making available reproduce the documents referred to in Article 100b (1).2. Member States shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by a member of the general public may be drafted in any of the official languages of the Union which are official languages in the Member States where the medicinal product is authorised. The reply shall be drafted in the language of the request.
Article 100f
1. Member States shall, without creating a disproportionate burden for the marketing authorisation holder, ensure that marketing authorisation holders make information provided in accordance with this Title accessible to persons with disabilities.2. To ensure accessibility of information on a medicinal product provided by marketing authorisation holders through the Internet, the websites concerned shall conform to the World Wide Web Consortium’s (W3C) Web Content Accessibility Guidelines version 2.0, Level A. The Commission shall make those guidelines publicly available.
The Commission shall be empowered to adopt delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c to amend this paragraph to take account of technical progress
Article 100g
1. Member States shall ensure that information on authorised medicinal products subject to medical prescription is made available by the marketing authorisation holder to the general public or members thereof after it has been approved by the competent authorities.However, the documents referred to in Article 100b(1) shall not require further approval before they are made available to the general public or members thereof in addition to their approval in the context of a marketing authorisation procedure.
2. By way of derogation from paragraph 1, Member States may rely on other mechanisms for the control of information after it has been made available, on any of the following grounds:
(a) such mechanisms already existed on 31 December 2008,
(b) a system of control of information before it is made available is not compatible with the constitutional rules of the Member State concerned.
Such mechanisms shall ensure
a level of adequate and effective control equivalent to the approval referred to in paragraph 1 .
3. After consulting the Member States and stakeholders, the Commission shall draw up guidelines concerning information allowed under this Title The Commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained.
Article 100h
1. Member States shall ensure that marketing authorisation holders register Internet websites containing information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.After registration of the Internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holders on other of their Internet websites containing information on medicinal products throughout the Union if the contents are identical.
2. Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites unless they have also been registered in accordance with that paragraph. Those websites shall identify the competent authority which granted the marketing authorisation and its website address.
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited content actively distributed to the general public or members thereof.
3. The Member State where the Internet website has been registered shall be responsible for the control of the information made available at the time of registration and of subsequent information in accordance with Article 100g and for the monitoring of such information, in accordance with Article 100j
4. A Member State shall not adopt any measure with regard to the content of an Internet website which reproduces an Internet website registered with the national competent authorities of another Member State, except on the following grounds:
(a) If the Member State of registration monitors the information after it has been made available in accordance with Article 100g(2), a Member State may require that the information is approved by the competent authorities before it is reproduced on a website in that Member State;
(b) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the information made available on the Internet website registered with the national competent authority of another Member State.
(c) If a Member State has reasons for doubts as to whether the information made available on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
5. Member States shall require marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include the following therein:
(a) in addition to the statements listed in Article 100d(2), a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. In cases where the information is not subject to approval prior to its being made available pursuant to Article 100g(2), Iit shall also specify that the fact that the website is registered and monitored does not necessarily mean that all the information on the website has been subject to prior approval.
(b) a link to the European medicines web portal referred to in Article 26 of Regulation (EC) No 726/2004.
6. Member States shall ensure that information on medicinal products authorised in accordance with Regulation (EC) No 726/2004 is not made available on Internet websites that they have registered until the information has been approved by the Agency in accordance with Articles 20b and 20c of that Regulation.
Article 100i
1. Member States shall take appropriate measures to ensure that the provisions of this Title are applied and that adequate and effective measures are adopted to sanction non-compliance with those provisions. Such measures shall include the following:(a) the determination of the penalties which shall be imposed should the provisions adopted for the implementation of this Title be infringed;
(b) the obligation to sanction cases of non-compliance;
(c) the conferment of powers on the courts or administrative authorities enabling them to order the cessation of making available information that does not comply with this Title or, if such information has not been made available but this is imminent, to prohibit the making available of such information ;
(d) the possibility to publish the name of marketing authorisation holders responsible for making available information not compliant with this Title.
2. Member States shall make provision for the measures referred to in paragraph 1 to be taken under an accelerated procedure either with interim effect or with definitive effect.
3. Member States shall ensure that marketing authorisation holders are represented and heard in any consideration of a case in which they are accused of non-compliance with the provisions set out in this Title. The marketing authorisation holders shall have the right to appeal any decision to a judicial or other body. During the appeal procedure the making available of information shall be suspended until a decision to the contrary is taken by the responsible body.
Article 100j
Member States shall ensure that marketing authorisation holders, through the scientific service referred to in Article 98(1):(a) keep available for the competent authorities responsible for monitoring information on medicinal products, a sample of all information made available in accordance with this Title and information on its volume , together with a statement indicating the persons to whom it is addressed, the method of communication and the date on which the information was first made available,
(b) keep available for the competent authorities responsible for monitoring information on medicinal products, the replies made in accordance with this Title together with a statement indicating the persons to whom they are addressed,
(c) ensure that information on medicinal products by their undertaking complies with the requirements of this Title;
(d) supply the authorities responsible for monitoring information on medicinal products with the information and assistance they require to carry out their responsibilities;
(e) ensure that the decisions taken by the authorities responsible for monitoring information on medicinal products are immediately and fully complied with.
Article 100k
Information on homeopathic medicinal products referred to in Article 14(1) that have been classified as prescription-only shall be subject to the provisions of this Title.Article 100l
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title, after consultation of stakeholders, and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council."(9) In Article 121a(1), the words 'Article 22b, 47, 52b and 54a' are replaced by 'Articles 22b, 47, 52b, 54a and 100f (2)'.
(10) In Article 121b(1), the words 'Articles 22b, 47, 52b and 54a' are replaced by ' Articles 22b, 47, 52b, 54a and 100f(2)'.
(11) In Article 106, the following first sub-paragraph is inserted:
"Each Member States shall ensure that objective, unbiased information is made available to general public or members thereof on medicinal products placed on the market on its territory".
(12) Article 107i(1) is replaced by the following:
"1. A Member State or the Commission, as appropriate, shall initiate the procedure provided for in this section, by informing the other Member States, the Agency and the Commission , in any of the following cases:
(a) it considers suspending or revoking a marketing authorisation;
(b) it considers prohibiting the supply of a medicinal product;
(c) it considers refusing the renewal of a marketing authorisation;
(d) it is informed by the marketing authorisation holder that, on the basis of safety concerns, he has interrupted the placing on the market of a medicinal product or has taken action to have a marketing authorisation withdrawn, or that he intends to do so, or has not applied for the renewal of a marketing authorisation;
(e) it considers that a new contraindication, a reduction in the recommended dose, or a restriction to the indications is necessary.
The Agency shall verify whether the safety concern relates to medicinal products other than the one covered by the information, or whether it is common to all products belonging to the same range or therapeutic class.
Where the medicinal product involved is authorised in more than one Member State, the Agency shall without undue delay inform the initiator of the procedure of the outcome of this verification, and the procedures laid down in Articles 107j and 107k shall apply. Otherwise, the safety concern shall be addressed by the Member State concerned. The Agency or the Member State, as applicable, shall make information that the procedure has been initiated available to marketing authorisation holders."
(13) Article 123(2) is replaced by the following:
"2. The marketing authorization holder shall be obliged to notify Member States forthwith of any action taken by him to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action. The marketing authorisation holder shall in particular declare if such action is linked to any of the grounds set out in Articles 116 and 117. In such case, Member States shall ensure that this information is brought to the attention of the Agency."
Article 2
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.