How do I identify imported products
Import / re-import / parallel import ...
Are there any analytical differences?
The ZL is increasingly receiving parallel imports for investigation because the users of the preparations reported side effects, ineffectiveness, weakening or changes in effect, while they had always tolerated the "original" well and found it effective.
The ZL takes each of these complaints seriously. Despite drugs containing the same active ingredients, it cannot be ruled out that z. B. a different ratio between active ingredients and excipients, a varying excipient composition and / or the type of pharmaceutical processing can lead to "individually perceptible" differences in the release of active ingredients and the active profile. However, these individually perceived differences cannot be verified analytically. The ZL orients its investigations to the specifications of the pharmacopoeias or the specifications of the approval dossiers and cannot carry out any comparative bioavailability studies on the complaining patient.
A drug regularly complained about because of its ineffectiveness is Viagra, which is sold in parallel®. This is a medicinal product that has been centrally approved by the EMA (authorization holder and "normally" pharmaceutical company: Pfizer Ltd., Kent, UK, authorization number: EU / 1/98/077 /…), in which the imported goods as well as the original preparation in the same manufacturing facility (Pfizer PGM, 37530 Pocé-sur-Cisse, France) with identical composition and released. The importers (e.g. axicorp, kohlpharma, Emra-med, EurimPharm, CC Pharma) only take on the parallel distribution and, if necessary, the outer packaging of the preparation.
So far there have been no differences in the ZL between "original goods" and Viagra sold in parallel® detected. The products complained about contained the specified active ingredient in the declared amount. Anomalies or significant differences in terms of disintegration time or release could not be confirmed analytically in any case.
Not afraid of parallel and imported goods?
The answer to this question is yes and no. Because the (complex) parallel and re-import business also opens another door for counterfeiting. On the one hand, due to the common practice of repackaging: The drug may be cut up, portioned differently, rearranged and pasted with German-language labels, and any "forgery-proof, anti-counterfeiting" measures applied by the original manufacturer are destroyed. On the other hand, the increasing number of wholesalers and middlemen means that a drug goes through many hands in many places before it reaches the patient. A bypassing the actual target country and selling in another country, where higher prices are tempting, is also not ruled out. Of course, this affects the supply systems, can lead to bottlenecks and above all increases the opportunity for counterfeits to be smuggled in.
That is why every reference by patients to possible quality defects, especially with these goods, should be taken very seriously.
ContactCentral Laboratory of German Pharmacists Carl-Mannich-Str. 20, 65670 Eschborn www.zentrallabor.de
DAZ 2011, No. 40, p. 102
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