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1 PROPOSAL of law No. 204/X explanatory memorandum on the use of legislative authorization granted by law No. 8/2001, of 21 may, the Government approved, by Decree-Law No. 288/2001, of 10 December, the Statute of the order of pharmacists, in whose article 77 if defines the content of the pharmaceutical Act, which integrates both the medicinal product for human use as the veterinary medicinal product , a set of activities that article 76 of the indicated diploma recently, in exclusivity, the competence and the responsibility of the pharmacist. Are concerned, namely, registration, manufacture, control, storage, storage, wholesale and retail distribution, information, consultation, monitoring, surveillance and supervision of the distribution, dispensing and use of the medicinal product for human use as the veterinary medicinal product, which are, without distinction, subject to the same situation of exclusivity. With regard, however, to the veterinary medicinal product, die today, in view of the developments, arguments that support that exclusivity. Furthermore, the exercise of pharmaceutical activity, as a primary purpose, the person of the patient, as significantly if records in article 72 of that Statute, no reason of principle imposes the maintenance on that reservation, in respect of the veterinary medicinal product in the sphere of the pharmacist. Indeed, the differentiation of the status of the medicinal product for human use in respect of the veterinary medicinal product has been progressively assert itself: thus, for example, Decree-Law No. 72/91, of 8 February, which defined the status of the medicinal product for human use, included in the concept of medicine contained in subparagraph (a)) of your article 2, ' any substance or combination of substances which present healing or preventive properties of the 2 diseases and their symptoms , the man or animal '. This status of the medicinal product for human use came in 2006, to be replaced by Decree-Law No. 176/2006 of 30 August, which in the definition of medicinal product given in ee) (a) of paragraph 1 of article 3, your limited to ' any substance presented for treating or preventive diseases in human beings '. In the same logic of differentiation of the system of medicine for human use in relation to veterinary medicine, came as a result of the Restructuring program of the Central Administration of the State (PRACE), the supervision of the veterinary medicinal product to be integrated into the Mission of the Directorate-General of veterinary, pursuant to h) article 14 of Decree-Law No. 209/2006 of 27 October While the corresponding INFARMED's assignments in the field of medicines, were confined to medicine for human use, as is apparent from paragraph 1 (a)) of paragraph 2 of article 17 of Decree-Law No. 212/2006 of 27 October. As a result of this development, also its marketing fee, which was initially subject to the same billing scheme that the medicinal product for human use, for imposition of Decree-Law No. 282/95, of 26 October, came to be this highlighted, by effect of the recent publication of Decree-Law No. 253/2007, of July 9, it attaches to the Veterinary Directorate responsible for your recovery in respect of the veterinary medicinal product as far as pharmacological, immunological and assigned their product exclusively to the financial support of actions related to quality assurance for veterinary medicinal products, the National System of pharmacovigilance and Veterinary Toxicology for veterinary medicinal products and of the national plan for control of use of medicinal products to farm animals, and even for actions related to training and professional animal health information.
3 on the other hand, Community legislation, has collected and systematized in two directives, the status of the medicinal product for human use and the status of the veterinary medicinal product, respectively, Directive No. 2001/83/EC of the European Parliament and of the Council of 6 November and Directive No 2001/82/EC of the European Parliament and of the Council of 6 November. Thus, the status of the veterinary medicinal product differentiation, should be definitively established in the internal planning for the necessary transposition of Directive No. 2001/82/EC of 6 November, of the European Parliament and of the Council amended by Directive No. 2004/28/EC of 31 March, the European Parliament and of the Council establishing a true code of the veterinary medicinal product. With this transposition occurs check that, the universe of professions that, today, have adequate knowledge to the proper and safe handling of the veterinary medicinal product is not restricted to the pharmacist, as shown by the way the Community legislation itself, in which, inter alia, the ' qualified person ' to be designated by the holder of the authorisation of veterinary medicinal products, is defined as the holder of a diploma certified by a cycle of university education in the disciplines of Pharmacy , medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology and in accordance with paragraph 2 of article 53 of Directive 2001/82 no/EC of 6 November, of the European Parliament and of the Council amended by Directive No. 2004/28/EC of 31 March. Will be as timely, in view of the imminent transposition of that directive, prevent all activity related to the veterinary medicinal product, be hived off, without any justification, on the contents of the pharmaceutical Act, and consequently, under the exclusive competence of the pharmacist. We must, therefore, introduce amendments to that Statute, what this condition in respect of the veterinary medicinal product, the competition and the free exercise of the provision of services in this field.
It should also be mentioned, as set out in recommendation No 1/2006 of the competition authority, issued in the wake of the Lisbon European Council in March 2000, in which it was adopted an economic reform programme, where he underlined the importance of competition in the context of the services provided by liberal professions, with the development of initiatives by the Commission, in order to encourage the authorities of the Member States to undertake reforms in order to eliminate regulatory restrictions no objectively justified or replace them with less restrictive rules, so as to create greater competition in those professions. Were heard the Government organs of the autonomous regions and the order of pharmacists. So: under d) of paragraph 1 of article 197 of the Constitution, the Government presents to the Assembly of the Republic the following Bill: single Article amendment to Decree-Law No. 288/2001, of 10 November the article 76 of the staff regulations of the order of pharmacists, approved by Decree-Law No. 288/2001, of 10 November, is replaced by the following : ' 76 [...] 1. The pharmaceutical Act is the exclusive competence and responsibility of pharmacists.
5 2. The preceding paragraph shall not apply to veterinary medicine.»
Seen and approved by the Council of Ministers of 17 April 2008 Prime Minister the Minister of Parliamentary Affairs Minister Presidency
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