1. The supply of medicated feed to animal holders shall be subject to the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription and to the conditions laid down in paragraphs 2 to 6.

A complementary approach that both promotes the principle of better regulation and ensures a high level of protection can be achieved where the products made by the manufacturers of optical radiation sources and associated equipment comply with harmonised standards devised to protect the health and safety of users from the hazards inherent in such products; accordingly, it is not necessary for employers to repeat the measurements or calculations already undertaken by the manufacturer to determine compliance with the essential safety ...[+++]requirements of such equipment as specified in the applicable Community Directives, provided that the equipment has been properly and regularly maintained.

A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market; A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMEA), to assess advanced therapy products and follow scientific developments in the field; Tailored technical requirements, which are adapted to the particular scientific characteristics of these products; Detailed guidance for the application of good manufacturing practice and good clinical practice to advanced therapies; Strengthened requirements for risk management and po ...[+++]st-authorisation traceability; A system of low-cost, top-quality scientific advice for the industry, provided by the European Medicines Agency; Financial and administrative incentives for small and medium-sized enterprises developing advanced therapies.

The Community harmonisation measures previously adopted laid down only limited requirements in respect of the manufacture and labelling of tobacco products (Directive 89/622 on labelling and Directive 90/239 on the maximum tar yield of cigarettes).

The Act provided for: a prohibition against importing or exporting drugs at a port not designated for that purpose by federal authorities; the issue of permits for the import, export, manufacture, sale and distribution of drugs; the imposition of criteria regarding packaging and labelling of packages containing such substances; an obligation for businesses to keep a record of their drug importing, exporting, manufacturing, sale and distribution activities duly authorized by federal authorities; an obligation for physicians to provide the information requested by federal authorities concerning the purchase, manufacture or ...[+++]prescription of medications containing drugs; an obligation for pharmacists to keep a record of their purchases and sales of drugs, the preparation of their own medications containing such substances and renewals of prescriptions signed by a physician; [58] and the authorization to sell medications (such as ointments and liniments) containing very small quantifies of scheduled drugs without a permit, provided they were not administered to children under two years of age and met certain labelling criteria.

2. A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent a ...[+++]uthorities.