Law 6-2-96 n. 52
LAW 6 February 1996, n. 52.
Provisions for the fulfillment of obligations deriving from Italy's membership of the European Communities - Community law 1994.
The Chamber of Deputies and the Senate of the Republic have approved:
THE PRESIDENT OF THE REPUBLIC
PROMULATE
the following law:
TITLE I
GENERAL PROVISIONS ON PROCEDURES
FOR THE FULFILLMENT OF COMMUNITY OBLIGATIONS
Article 1.
(Delegation to the Government for the implementation of community directives).
1. The Government is empowered to issue, within the term of one year from the date of entry into force of this law, the legislative decrees containing the regulations necessary to implement the directives included in the list in Annex A. Where applicable delegations to the Government for the enactment of legislative decrees containing the rules necessary to implement the community directives or the enactment of implementing regulations is envisaged, the general principles and criteria must always include those of full transparency and impartiality of the activity administration, in order to guarantee the right of access to documentation and correct information of citizens, as well as, in the appropriate ways, the rights of consumers and users.
2. If, as a result of directives notified in the second half of the year referred to in paragraph 1, the discipline resulting from directives included in the list referred to in Annex A is modified without introducing new rules of principle, the deadline is extended by six months.
3. The legislative decrees are adopted, in compliance with article 14 of the law of 23 August 1988, n. 400, on the proposal of the Minister for the coordination of European Union policies, jointly with the Ministers with prevailing institutional competence for the matter and in concert with the Ministers of Foreign Affairs, of Justice and the Treasury, if not proposers.
4. The outlines of legislative decrees implementing the directives included in the list referred to in Annex B, following a preliminary resolution of the Council of Ministers, are transmitted, within the term referred to in paragraph 1 or paragraph 2, to the Chamber of the deputies and to the Senate of the Republic so that the opinion of the Commissions competent for the matter is expressed on them within forty days from the date of transmission. After this deadline, the decrees are adopted. If the term established for the opinion of the Commissions expires in the thirty days prior to the expiry of the term established in paragraph 1 or paragraph 2, or subsequently, the expiry of the latter is extended by ninety days.
5. Within two years from the date of entry into force of this law, the Government may issue supplementary and corrective provisions, in compliance with the principles and directive criteria established by it, with the procedure indicated in paragraphs 3 and 4.
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CHAPTER V
HEALTH AND ENVIRONMENT
Article 28.
(Medicines for human use: delegation criteria).
1. The implementation of Council Directive 93/39/EEC will be guided by the following guiding principles and criteria:
a) provide that the Minister of Health sends Parliament an annual report on the activity of the pharmacovigilance service;
b) provide that the person responsible for placing a medicinal product on the market is established in the territory of the European Community specifying that, for medicinal products already authorized on the date of entry into force of the legislative decree, this provision applies on the occasion of the five-year renewal of the authorization upon placing on the market;
c) provide that the Single Drug Commission referred to in article 7 of the legislative decree of 30 June 1993, n. 266, prepares the evaluation report on the new medicinal products for which marketing authorization is requested, according to the provisions of the Community legislation;
d) provide that the tariffs and fees payable by the interested parties for the examination of applications for authorization to market medicinal products or applications for the modification of authorizations already granted are not less than one tenth nor greater than one fifth of the amounts of the corresponding fees the European Medicines Evaluation Agency;
e) establish the minimum requirements that the person in charge of pharmacovigilance and the relative service must possess; this person in charge must be a person distinct from the person in charge of the scientific service envisaged by the legislative decree of 30 December 1992, n. 541, but must be able to use all the data of this service; the person in charge of pharmacovigilance performs his duties also with regard to medicinal products whose marketing is entrusted to other companies, pursuant to article 7 of the aforementioned legislative decree n. 541 of 1992;
f) provide that minor changes to an authorization already granted can be made by simple notification by the interested party, similarly to what is provided for medicinal products governed by Regulation (CB) no. 2309/93 of the Council.
2. A pharmacovigilance service is set up within the Ministry of Health, within the limits of the appropriations entered in the estimate of the expenditure of the same Ministry and of the quotas foreseen by the staff, called the Department for the evaluation of medicinal products and pharmacovigilance, similar to the services of detection and surveillance established in Europe, also in order to ensure the safety and correct use of drugs. The head of the Department must meet the technical and scientific requirements, established by regulation to be issued by the Minister of Health in compliance with those required internationally, which include transparency relationships with manufacturing companies. The Department makes use of the Higher Institute of Health, the Single Drug Commission, the Higher Health Council, the Regions, local health units, hospitals, general practitioners, pharmacies, consumer associations, drug manufacturers and sales reps. The Department also provides for the performance of any other function in pharmaceutical matters and medical-surgical aids already under the responsibility of the Department of Prevention and Medicines referred to in article 4, paragraph 4, of the decree of the President of the Republic of 2 February 1994, no. 196, for the elaboration of studies and research on the use of drugs, on epidemiology and etiology, on active pharmacovigilance and on the interpretation of the data obtained as well as for the preparation of population registers for pharmacoepidemiology to be allocated to the regions. With the regulation that defines the organization of the Department's competences, the competences of the Department of Prevention and Medicines defined in article 4, paragraph 4, of the decree of the President of the Republic February 2, 1994, n. 196.
Article 29.
(Cosmetic products: delegation criteria).
1. The implementation of Council Directive 93/35/EEC will be guided by the following guiding principles and criteria:
a) provide that the Ministry of Health collects data to be transmitted annually to the Commission of the European Communities on the trials of cosmetic products carried out on animals;
b) define the professional profile of the cosmetic product safety assessor, providing for the mutual recognition regime of the diploma in the European context as governed by the legislative decree of 27 January 1992, n. 115;
c) provide that the responsibility for the safety assessment can be assumed by the technical director already established by the law of 11 October 1986, n. 713, if this is in possession of the requirements referred to in letter b);
d) regulate the obligations of manufacturers or suppliers of raw materials intended for use in cosmetic products to provide information relating to the physical-chemical and microbiological specifications of said raw materials, as well as their toxicological profile and the irritating and allergenic power of the product finished;
e) identify a surveillance system on cosmetic products aimed at highlighting and collecting data, as well as assessing any undesirable effects caused by their use; the authority in charge and identified for this purpose collects the information from the individual regions and autonomous provinces;
f) designate the central offices competent to request the information referred to in number 12), paragraphs 1 and 4, of article 1 of Directive 93/35/EEC;
g) provide for the methods that allow the immediate identification of the place where the information on the cosmetic product is filed;
h) in compliance with the competences of the regions and autonomous provinces of Trento and Bolzano, provide for an organic system of supervision and control of the production plants and importers' warehouses, ensuring effective prevention in the area under the responsibility of the health structures;
i) identify the methods for applying the Community procedure relating to the conditions according to which a manufacturer for reasons of confidentiality can request the non-inclusion of one or more ingredients in the list established by Community legislation;
l) identify the procedures for the correct declaration of the list of ingredients to be reported on the product packaging.
2. It is mandatory to comply with the provisions and deadlines set out in number 3) of article 1 of directive 93/35/EEC, regarding experimentation on animals.
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This law, bearing the seal of the State, will be included in the Official Collection of Regulatory Acts of the Italian Republic. Whoever is responsible is obliged to observe it and to have it observed as a state law.
Given in Rome, this 6 February 1996
SCALFARO
DINI, President of the Council of Ministers
FANTOZZI, Minister for the coordination of
the policies of the European Union
Seen, the Keeper of Seals: Dini