Personalized medicines, productivity

The manufacture of all investigational medicinal products (including placebo) that are intended for a clinical trial must be authorised and conducted according to Good Manufacturing Practice (GMP). This should be supervised and certified by a Qualified Person . An import authorisation is required for any product from outside the EU, which should also be manufactured to GMP standards. (See Ghapters 11 and 12 for information on GMP, manufacturing authorisations and Qualified Persons.)... 

Pharmaceutical products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products. 

Most of the information sought is similar to the FDA s IND requirements. One major difference is that a Qualihed Person has to certify that the investigational medicinal product (IMP) is manufactured according to GMP The Competent Authority has the right to inspect the manufacturing facility for GMP compliance, the preclinical facility for GLP compliance, and the clinical trial sites for GCP compliance. 

No person shall issue an advertisement relating to a relevant medicinal product unless that advertisement complies with the particulars listed in the SPC characteristics. 

No person shall issue a misleading advertisement relating to a relevant medicinal product. 

A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supphed in response to a bom fide unsoUcited order formulated in accordance with the specifications of an authorised health professional and for use by his individual patients on his direct personal responsibility. 

Paragraph 4 sets out an exemption in certain circumstances for medicinal products not requiring a prescription for sale or supply, which are prepared by, or under, the supervision of a pharmacist and are sold or supplied to a person exclusively for use by him in the course of his business for the purpose of administration to one or more persons. 

Paragraph 6 requires any person selling or supplying a relevant medicinal product to maintain, for a period of at least 5 years, records showing ... 

The person responsible for the marketing of a medicinal product shall be obliged to notify the Member States concerned forthwith of any action taken by him to suspend the marketing of a product or to withdraw a product from the market, together with the reason for such action if the latter concerns the efficacy of the medicinal product or the protection of the public health. Member States shall ensure that this information is brought to the attention of the Committee. 

Under section 118 of the Act, all data submitted by a company in support of an application to conduct clinical trials or market a medicinal product are confidential indeed even the existence of such an application is confidential. Breach of confidentiality attracts penalties and any person guilty of an offence under this section shall be liable (1) on summary conviction, to a fine not exceeding 400 (2) on conviction on indictment, to a fine or to imprisonment for a term not exceeding 2 years or to both. ... 

Insofar as the provisions laid down in (a), (b) or (c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported into another Member State together with batch release certification signed by the qualified person. 

Any person engaging in activities as the qualified person referral to in Article 21 of Directive 75/319/EEC as regards investigational medicinal products at the time when this Directive is applied in the Member State where that person is, but without complying with the conditions laid down in Articles 23 and 24 of that... 

Use this website of the National Library of Medicine to learn more about the chemical nature of various household chemicals such as personal care products, arts and crafts, pet care products, pesticides, yard care products, auto products, and more. 

Sulfonation and sulfation processes are utilized in the production of wateT-soluble anionic surfactants as principal ingredients in formulated light-duty and heavy-duty detergents, liquid hand cleansers, general household and personal care products, and dental care products. Other commercially significant product applications include emulsifiers, lube additives, sweeteners, pesticides, medicinals. ion-exchange resins, dyes and pigments. 

Applications for BMs are used to contain many different products that include foodstuffs, beverages, household products (appliances, air conditioners, furniture at home/office/hospital/sports arenas, etc.), personal care products, medicine/pharmaceutical products, automotive parts [bumpers, spoilers, air ducts, seat backs, etc.], construction panels, tote boxes, trays, leisure items (toys, floatation, marine buoys, canoes, sailboards, sports goods, etc.), industrial parts (business machines, tool boxes, trash containers, hot water tanks, etc.), and so on.215-217... 

This latter operation has now been completed for approximately 90 percent of MAs. PlLs have now been approved for most authorised medicinal products. The holder of the MA is also required to employ a person who is competent to take full responsibility for compliance of the information and publicity with the regulations and for consistency with the data sheets and patient leaflets accepted at (re)registration. This person has to be a registered pharmacist or physician. For veterinary products this can also be a veterinarian. 

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