August 1 Implementation Of Shenyang, "drugs And Medical Devices Regulations" - Drug

August 1, the "drugs and Shenyang Medical Devices Supervision and management measures "into effect

. This is the first nationwide local government introduced drugs and medical equipment to government regulations.

8 1st, Shenyang Food and Drug Administration held a "implementation of the" Shenyang Pharmaceutical and Medical Devices Regulations "to ensure Austrian Cup in Shenyang drugs and medical devices safe" activities. Shenyang Food and Drug Administration approval system interpretation of the relevant person in charge "approach." More than 20 food and medicine safety of the community hot spot "approach", have indicated that a more in-depth study "approach", and so carry out social supervision.

Core Tips "Shenyang Pharmaceutical and Medical Devices Regulations" from the August 1 implementation, it has been 3 days. 3 days, the only one that medicines and medical equipment will be integrated with supervision and management of government regulation which has aroused widespread concern and hot.

This "approach" is the first Department of Drugs and Medical Devices government regulations, which allow ease of drug safety in Shenyang city building laws to go by, "approaches" in the long break the law enforcement is encountered in practice various issues, but also this has created a comprehensive, full coverage, the whole process of the "three full" type of dynamic control mode.

Flow: re-regulate the retail Individual retail pharmacies in the past there with a drug phenomenon in several counter sales, so that when a consumer buys the medicine inconvenience. The "Measure", the same drugs can not be placed in different counters.

Law the new regulations, "Measure" counter drugs, can not put drugs shelf life than other commodities, it can not operate the premises at the counter or display goods on the same drugs. Prevention of cosmetics, Health Products Posing as drug sales and so eliminate the rental counter drugs such acts as the retail business.

The same time, pharmaceutical production and business enterprises in the food and drug supervision and administration shall not be approved by the department store or sell drugs outside of a venue. This regulation is intended to address undocumented business activities, including some enterprises to set up an office in the name of unauthorized dealing in drugs and other behaviors.

Hot community Shenbei Food and Drug Safety Oversight demonstration station in the anthology, said drug distribution channels are very important, this "approach" provides that "drug manufacturers purchase channels particularly demanding, are not allowed from Drug retailers buy drugs. "

I think the pharmaceutical companies and wholesale and retail sales business requires a different, higher threshold of wholesale enterprises require complete control over the flow of drugs sold, and retail pharmacies is terminal for the public use of drugs, relatively low threshold, no control sales flow. Once the drug manufacturers in procuring medicines from the retail business, it is difficult to control the flow of drugs, prone to problems. Therefore, enterprises should strictly channels to purchase drugs.

Production: the source of loopholes Past individual enterprises use outdated API And medical supplies, but they produced the required medicines, which was difficult to define in law enforcement. The "measures" API And pharmaceutical excipients standards were refined. Including its production techniques, prescription and prescription volume of the feed ingredients, and in full accordance with the approved standard operation.

The new regulations Act "means the" fifth stipulates: drug manufacturers produced drugs or medical preparation Preparation May never have the drug production, wholesale and business qualifications of business purchase bulk drugs and pharmaceutical excipients; not be identified without using the mark or over the period of validity of APIs and pharmaceutical excipients; not be inconsistent with the law and regulations and the State mandatory standard API, medical supplies put into production; should not be used without approval of bulk drugs and pharmaceutical excipients.

Community hot Big South full of department stores, said Chairman Liu Fu, the "measures" will be presented in a creative way to obtain a drug approval number of the auxiliary is defined as "pharmaceutical excipients", and bulk drugs, excipients procurement channels to do the norm, and clearly not never have a health or pharmaceutical wholesale business enterprises qualified purchase raw material and pharmaceutical excipients. This is the source of the good production off, close the loopholes.

Penalty: very informative articles "Drug Administration Law" on some issues directly related to the quality of medicines made mandatory, but no corresponding penalty, execution is not enough. "Measures" worked out in detail the circumstances are serious, given a heavier punishment of violations.

Law the new regulations "means" in Article 6 sets out in detail the food and drug supervision and management department may seal during an inspection, seizure medicines. seventeen to the second nineteen for pharmaceutical production and medical equipment manufacturing enterprises, enterprises law, the specific penalties for violations.

Community hot old CAST Shenyang Medical Committee chairman, former Secretary of Shenyang Wang Tingxiang Health, said: "This" means "releasing, do Shenyang Pharmaceutical Affairs is an important work weapons, but also realized I have not finished the wish that a more detailed specification in Shenyang, drugs and medical devices work. "" approach "to overcome past behavior does not provide what acts are serious, resulting in difficult law enforcement situations details the specific acts serious. More rational and more systematic.

by: gaga

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