Netherlands, drug

Netherlands drug regulation now follow European Union rules. For example, GMP inspection is based on the 1983 European Union guidelines for GMP. Since 1 January 1995, a European procedure for registration has operated in the Netherlands. Now two types of trade licences exist a European licence and a national licence. Products with a European licence may be sold throughout the whole European Union, while the national licences are only valid for the country in which the licence was issued by means of the national registration procedure. 

Amsterdam, The Netherlands Drugs used in ocular treatment... 

Van Noord C, Dieleman JP, van Herpen G, Verhamme K, SturkenboomMC. Domperidone and ventricular arrhythmia or sudden cardiac death a population-based case-control study in the Netherlands. Drug Saf 2010 33 1003-14. 

H. Kubinyi, eds., 3-D QSMR in Drug Design Theory, Methods and Applications, ESCOM Science Pubhshers, Leiden, The Netherlands, 1993. 

E. De Qercq, in V. Qaassen, ed.. Trends in Drug Research, Elsevier Science PubUshers, Amsterdam, The Netherlands, 1990, p. 133. 

H Kubinyi, G FoUcers, YC Martin, eds. 3D QSAR m Drug Design Recent Advances, Vols 2 and 3. Dordrecht, The Netherlands Kluwer Academic, 1998. 

In the Netherlands, associations of the pharmaceutical industry play a role in selfregulation, particularly in relation to drug promotion and advertising. Consumer organizations have a formal presence on the Social Health Insurance Council. 

All 10 countries have a registration system for allopathic/modem drugs, but only seven countries (Australia, Estonia, Malaysia, Netherlands, Tunisia, Uganda and Venezuela) make registration of herbal medicines compulsory. 

Drug regulatory function Australia Cuba Cyprus Estonia Malaysia Netherlands Tunisia Uganda Venezuela Zimbabwe... 

Only two of the 10 countries have devised specific measures for the benefit of consumers. The Australian dmg regulatory system also provides for the inclusion of consumer group representatives on various drug regulatory committees. The appeals system in the Netherlands is not limited to industry, but is also open to consumers. 

Table 10.3 presents for each country, for the period 1994-97, the number of drug samples submitted for testing, samples tested and the failure rate in those tests. Data are available from all 10 countries on the total number of samples submitted and the number of samples tested, and these show that seven countries— Australia, Cypms, Estonia, Malaysia, the Netherlands, Venezuela and Zimbabwe — have been able to meet the demand for testing (92-100%). Uganda has a relatively low test rate of 56% for the submitted samples, followed by Cuba and Tunisia at 72% and 88%, respectively. The lack of certain equipment and materials, such as reference standards and reagents, constrains analysis in Cuba, Cyprus, Uganda and Zimbabwe. 

Each of the countries operates a quality analysis system for post-marketing control of drug quality, albeit with vast differences in capacity. Data on the outcome measure for drug quality— the number of dmg samples that failed quality tests compared with the total number of samples collected— are available in all the countries, except the Netherlands. Failure rates are high in some countries, e.g. Tunisia and Uganda. In Australia, high failure rates are found for herbal and other complementary products, compared with prescription dmgs. Empirical data on sanctions applied in such instances are not available. 

Landelijke Registratie Evaluatie Bijwerkingen [National Registration and Evaluation of Adverse Drug Events] (Netherlands)... 

Malaysia Adverse Drug Reaction Advisory Committee Medicines Control Agency of Zimbabwe Medicines Evaluation Board (Netherlands)... 

C. sativa is cultivated for several purposes. Actually, the main legal purpose is the production of hemp fibers and pulp. From these materials paper, clothes and ropes are made [12] and several Western coimtries have already legalized the cultivation of C. sativa for these purposes. In research, the drug-type of C. sativa is also cultivated, however, only for the investigation and determination of forensic studies for chemotype separation. The growth for medicinal purposes is hardly performed, hi the Netherlands C. sativa is cultivated for medicinal purposes under strictly controlled regulations by the company Bedrocan. In this chapter we discuss basic aspects of the cultivation of C. sativa and the optimization of THC content in the plant. 

P. Furst, LC-MS a powerful tool in residue analysis of veterinary drugs, in Proceedings of the EuroResidue IV Conference, Veldhoven, The Netherlands, pp. 63-72 (2000). 

Hans E. Junginger Leiden/Amsterdam Center for Drug Research Leiden, The Netherlands Felix Theeuwes Alza Corporation Palo Alto, California... 

Source Courtesy of Professor D. K. F. Meijer, University Center of Pharmacy, University of Groningen, Groningen, The Netherlands. Other examples of drug targeting with glycoproteins and neoglycoproteins can be found in Ref. 235. 

Drug solutions and implantation of osmotic mini-pumps Physostigmine hemisulphate and procyclidine hydrochlorid were obtained from Sigma (St.Louis, U.S.A.), scopolamine hydrobromid from Merck (Darmstadt, Germany), atropine sulphate was obtained from ACF (Amsterdam, The Netherlands), and diazepam from Roche (The Netherlands). HI-6 was made available by the Defence Research Establishment, Suffield, Canada. Soman (O-pinacolyl methylphosphonofluoridate) was synthesised at TNO. Alzet Osmotic Mini-pumps with a constant delivery rate of 0.55 pl/hr (Model 2002, Alza Corp., Palo Alto, USA) were used to deliver PYR, PHY and SCO. The vehicle consisted of 20% propylene glycol, 10% ethanol and 70% water. The pumps were implanted subcutaneously under isoflurane/02 inhalation anesthesia. 

As the first published requirement for immunotoxicology evaluation of drugs, CPMPZSWP/1042/99 predictably was met with a combination of resistance and confusion. Much of this was allayed in a Drug Information Associated-sponsored workshop held in Noordwijk, The Netherlands in November of 2001. At this meeting, the intent of the guideline was clarified a summary of this workshop, as well as an update, has been published [44, 45],... 

In addition, societal expectations about substance use seem to be related to the susceptibility of societal members to experience drug-related problems. Many respected researchers believe that exposure to responsible substance use in society early in life may promote more moderate substance use in those societies where such behavior is sanctioned. One striking example is the Netherlands, which legalized marijuana use in coffee shops two decades ago but currently has lower marijuana abuse rates than the United States. We have no idea whether this kind of societal exposure would work with more potent substances than marijuana, although the same results have been found for alcohol in France, which has a much lower cirrhosis rate than the United States even... 

Davido, A., Hallali, P. and Boutchnei, T. (1989) Shock caused by glafenine. Apropos of 7 complications. Revue de Medecine Interne, 10, 113-117. van der Klauw, M.M., Wilson, J.H. and Strieker, B.H. (1996) Drug-associated anaphylaxis 20 years of reporting in The Netherlands (1974-1994) and review of the literature. Clinical and Experimental Allergy, 26, 1355-1363. 

Jhoti H, Leach A, eds. Structure-Based Drug Discovery, Springer, The Netherlands, 2007. 

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