Medicinal products
Off-label use of orphan medicinal products: a Belgian qualitative study
... of medicinal products for named patients and had been importing medicinal products that were not authorized there, even though authorized equivalents were ...
9
Translation of academic medicinal products towards clinical practice
... Of the interviewed PIs, 26% thought that ATMPs should become available according to the Tissues and Cells Directive, 2004/23/EC[19]. We conclude that PIs are not fully aware of the regulations toward implementation into ...
192
Clinical evidence for orphan medicinal products-a cause for concern?
... Committee for Human Medicinal Products (CHMP) of the EMA. The first part collects general descriptive infor- mation about the OMP and its marketing authorization. The second part focuses on the assessment ...
8
World health organization’s procedure for prequalification of medicinal products
... of medicinal products, quality assurance, biopharmaceutics and other relevant ...generic products, WHO may provide technical assistance to applicants regarding appropriate product information to be ...
5
Proposal for a Council Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of the national health insurance system. COM (86) 765 final, 23 December 1986
... -20· Whereas Member States have adopted measures of an economic nature on the marketing of medicinal products in order to control or reduce public health expenditures on medicinal produc[r] ...
33
International Logistics Criteria on Medicinal Products for Human Use
... Medicinal products for human use relates to international logistics of pharmaceutical raw materials to the world people’s health and life, therefore international logistics provider plays an important part ...
21
The European challenges of funding orphan medicinal products
... Prior to public reimbursement of pharmaceuticals and medical devices, cost-effectiveness and budget impact are increasingly applied evaluation criteria alongside other conditions. Pharmaceutical manufacturers tend to ...
8
First Commission report to the Council on the functioning of the Committee for Proprietary Medicinal Products and its impact on the development of intra-Community trade. Period 1977/1978. COM (79) 59 final, 22 February 1979
... of Procedure of the Co.aittee for Proprietary Mtdicin•l Products.. THE COMMITTEE FOR PliOPRIETARY MEDICINAL PRODUCTS,..[r] ...
64
Forward towards a European policy on medicinal products
... On 3 December 1990, the Council decided to consult the Economic and Social Committee, under Article 100a of the Treaty establishing the European Economic Community, on the Proposal for a[r] ...
54
Regulation of traditional and complementary medicinal products in Malaysia
... pharmaceutical products through the implementation of the relevant legislation by a competent workforce working together in strategic alliance towards improving the health of the ...
5
RICINUS COMMUNIS: PHARMACOLOGICAL ACTIONS AND MARKETED MEDICINAL PRODUCTS
... thousands of medicinal plants. The pharmacological activities reported in the present review confirm that the therapeutic value of Ricinus communis is much more. It is an important source of compounds with theirs ...
10
Comparing access to orphan medicinal products in Europe
... We found that more than a half of centrally authorised OMPs were available in the five selected countries, but that access to patients was further restricted by different national reimbu[r] ...
12
Economic and Social Consultative Assembly annual report 1989
... Community procedure for the establishment of tolerances for residues of veterinary medicinal products; veterinary medicinal products amending Directive 81/851/EEC; veterinary medicinal p[r] ...
164
Signature by the Community and the Member States of the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes. Communication from the Commission to the Council. Proposal for a Council Directive on the protection of animals used for experimental and other scientific purposes. COM (85) 637 final, 18 December 1985
... 2.- in respect of the testing of veterinary medicinal products 4, 83/228/EEC of 18 April 1983 and on the fixing of guidelines for the assessment of certain products .used in animal nutri[r] ...
46
1509th Meeting of the Council (Internal Market). Council Press Release 7450/91 (Presse 131), Brussels, 22 July 1991
... -4 ngslHllletu-Z \ 22.VII.1991 I,IEDTCINAL PRODUCTS Rational use of medicinal products for The Council reached a political human use agreement with a view to the establishnent of a conmo[r] ...
22
PHARMACEUTICAL RISK MANAGEMENT PLAN: A TOOL FOR PHARMACEUTICAL INDUSTRY
... to medicinal products including the assessment of effectiveness of the effectiveness of those activities ssessment means identifying and characterization the nature, frequency, and severity of the risk ...
6
Economic and Social Committee annual report 1989
... Community procedure for the establishment of tolerances for residues of veterinary medicinal products; veterinary medicinal products amending Directive 81/851/EEC; veterinary medicinal p[r] ...
162
Volume 9 | Issue 3 - 2019
... 8. Zakharochkina E.R. Pravovoye pole po formirovaniyu obshchego rynka lekarstvennykh sredstv Yevraziyskogo ekonomicheskogo soyuza [Legal field for the formation of the common market of medicinal products of ...
5
OVERVIEW OF BIOTECHNOLOGICALLY DERIVED PRODUCTS AND VARIOUS REGULATORY PARAMETERS FOR BIOSIMILARS IN EUROPEAN UNION
... authorized medicinal products and detect any change to their benefit-risk ...the medicinal product, including the measurement of their effectiveness in clinical ...biosimilar medicinal product ...
12
Alternate Vendor Development of Cycloserine API
... of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that ...
9