Traduction de «Participate in registration pharmaceutical products » (Anglais → Français) :

If the investigational medicinal product is not authorised, and does not have a marketing authorisation from a third country that is party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and is not manufactured in the Union, the following documentation shall be submitted:

I might point out as well that the changes that the Pest Control Products Act sought to accomplish were the following: clear requirements for the minister to give special consideration to children and to assess aggregate exposure and cumulative effects; clearer authority for the minister to refuse to consider an application or to maintain a registration if the applicant or registrant does not provide the information necessary to substantiate claims that the risks and value of the product are acceptable; mandatory reporting of advers ...[+++]e effects of registered pesticides; new opportunities for informed public participation in the pest management regulations; and strengthened measures to encourage compliance.

15.Manufacture of food products and beverages16.Manufacture of tobacco products17.Manufacture of textiles18.Manufacture of wearing apparel; dressing and dyeing of fur19.Tanning and dressing of leather; manufacture of luggage, handbags, saddlery, harness and footwear20.Manufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials21.Manufacture of paper and paper products22.Publishing, printing and reproduction of recorded media23.Manufacture of coke, refined petroleum products and nuclear fuel24.Manufacture of chemicals and chemical products25.Manufacture of rubber and p ...[+++]lastics products26.Manufacture of other non-metallic mineral products27.Manufacture of basic metals28.Manufacture of fabricated metal products, except machinery and equipment29.Manufacture of machinery and equipment n.e.c.30.Manufacture of office, accounting and computing machinery31.Manufacture of electrical machinery and apparatus n.e.c.32.Manufacture of radio, television and communication equipment and apparatus33.Manufacture of medical, precision and optical instruments, watches and clocks34.Manufacture of motor vehicles, trailers and semi-trailers35.Manufacture of other transport equipment36.Manufacture of furniture; manufacturing n.e.c.37.Recycling | None BGproduction of alcohol beverages, distillate and spirit is subject to registration and can be performed by entities registered under the Trade Law or under the legislation of an EU or EEA Member State.Production of tobacco products and processing of tobacco is subject to authorisation by the Council of Ministers and can be performed by entities registered under the Trade Law or under the legislation of an EU or EEA Member State.Reservation for exploitation of nuclear installation or equipment and disposal of nuclear fuel subject to licensing.Production, import and distribution of pharmaceuticals and veterinary medical products requires authorisation of the principal represen ...

(18) Having regard to the particular characteristics of these homeopathic veterinary medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without therapeutic indicat ...[+++]ions in a pharmaceutical form and dosage which do not present a risk for the animal.

Whereas, having regard to the particular characteristics of these medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those traditional homeopathic medicinal products which are placed on the market without therapeutic indications in a ...[+++]pharmaceutical form and dosage which do not present a risk for the patient;

In 2007 — this is five years ago — the U.S. Food and Drug Administration Amendments Act introduced severe penalties, including a $10,000 penalty per violation, per day, for non-registration or non-publication of results of Phase II to Phase IV trials of pharmaceutical products and medical devices.