Manual of medicines and chemical reagents and label management set

Manual of medicines and chemical reagents and label management set
General principles of the first chapter
The first is the management of manual of normative medicines and chemical reagents and label, basis " Pharmaceutical Affairs Law of People's Republic of China " and " Pharmaceutical Affairs Law of People's Republic of China carries out byelaw " make this provision.
The 2nd appears on the market in churchyard of People's Republic of China the medicines and chemical reagents of the sale, its manual and label ought to accord with the requirement of this regulation.
Manual of the 3rd medicines and chemical reagents and label are given by supervisory management board of national provision medicines and chemical reagents approve.
The label of medicines and chemical reagents ought to be a basis with the manual, its content must not exceed the range of the manual, must not imprint allusive curative effect, misdirect uses the character that publicizes a product with impropriety and label.
The 4th medicines and chemical reagents is packed must imprint according to the regulation have or stick have ticket, not any carry secretly is other characters that introduce or publicize product, enterprise, sound resembles etc data.
What production of drug production company sells for appearing on the market is the smallest pack must with the manual.
The character of manual of the 5th medicines and chemical reagents and label is stated ought to science, standard, accurate. Manual of blame prescription drug still ought to use the character that understands easily to state, so that judgement of patient proper motion, choice is mixed,use.
The character in manual of the 6th medicines and chemical reagents and label ought to clarity easy differentiate, the label ought to be clear about marked, must not lettering falls off stickup perhaps not the phenomenon such as the prison, must not with stickup, cut, the means such as alter undertakes revise or complementing.
The standardization Chinese character that manual of the 7th medicines and chemical reagents and label ought to use committee of job of national language writing to announce, increase other character to contrast, ought to state with the Chinese character to allow.
The 8th stems from protection public health and guidance are correct and reasonable the end that uses drug, drug production company can put forward actively to be in manual of medicines and chemical reagents perhaps is added on label note caution sign, supervisory management board of national provision medicines and chemical reagents also can ask medicines and chemical reagents produces an enterprise to be in the manual perhaps is added on label note caution sign.
Manual of medicines and chemical reagents of the 2nd chapter
The important and scientific data that manual of the 9th medicines and chemical reagents ought to include security of medicines and chemical reagents, effectiveness, conclusion and information, safety of guidance of in order to, reasonable use medicines and chemical reagents. The particular form of manual of medicines and chemical reagents, content and book write a requirement to by national provision medicines and chemical reagents supervisory management board is made and be released.
上一页12 3 4 5 下一页