health Resort has prepared a new list of medicines that may be sold outside pharmacies – it is an Annex to the draft amendments to the resolution ws. criteria for classification of medicinal products that can be traded on the turns pozaaptecznego and pharmacies.
Manual MZ long foreshadowed restrictions on the sale of drugs in shops and petrol stations. According to the Department, the appeal pozaaptecznym can’t be drugs that are potentially dangerous; besides the drugstore must sell drugs to use temporarily and they should not be in large packages.
in accordance with the draft, published on Monday, traded in the stores of General use and in specialized stores of medical supplies can only be: analgesics, nonsteroidal antiinflammatory drugs, drugs used in nicotine dependence, drugs used in diseases of the throat, antiseptic and disinfectant agents inhibiting peristalsis of the gastrointestinal tract, antihistamines, proton pump inhibitors and drugs used in inflammatory diseases of the oral cavity and pharynx containing only vegetable products.
In the list of specified requirements regarding the composition, power, pharmaceutical form and contents medicinal products in packaging or package size.
In the list may not be medicinal products whose names can mislead; where name matches the proper name or the name of a widely used (name of substance) medicinal products issued upon prescription; where uncontrolled use is associated with serious risk of side effects or overdose.
As noted in the explanatory Memorandum of the project, it includes the Main postulates of the chamber of Pharmacists and pharmaceutical manufacturers about the category of rooms in the TCI. When determining criteria were taken into account, above all, the safety of their application, requirements, storage and distribution, subject to the availability of medicinal products (especially from the standpoint of package size and dosage).
In work on the norm it is assumed that the drug is safe to use-it is the one substance is characterized by a wide therapeutic index and does not create risks of addiction. In addition, the active substance of the product – in effect, in the form of pharmaceuticals and the application offered for sale in stores for General use – was available without prescription in pharmacies, at least 5 years, and its permission to sell in the shops for General use will not increase the risks associated with its use.
the side effects that can accompany the use of such drugs can be severe, and the frequency of their occurrence has not increased clearly in the period of application of the product, which is issued by prescription; moreover, side effects and mode of action in the event of their occurrence, in exceptional cases, require medical supervision. The potential interaction of the product with components of food, alcohol and other drugs is only in exceptional cases result in significant risk to the patient. The product must be intended solely for oral use, with the exception of pulmonary antiseptics and disinfectants.
the Project supposes that the trade in stores for General use and in specialized medical supplies may not be admitted products, uncontrolled use is associated with serious risk of side effects or overdose. Cannot be also sold drugs in which the active substance or their compounds, are admitted to trading in Poland in medicines dispensed in pharmacies without a prescription for a shorter period than 5 years.
the Regulation should enter into force after 30 days since the announcement. Provided, however, “gradual, evolutionary understanding of entrepreneurs a new legal status” – they will be able within a period not exceeding 12 months from the date of entry into force of the new rules to trade pharmaceutical other than an update of relevant criteria.
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