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rules regarding importing drugs from outside the EU??

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  • rules regarding importing drugs from outside the EU??

    heya
    i am not quite sure about the movement of drugs internationally. i understand someone can apply for importing license to import some cheaper products from the EU, what about from non-EU countries?

    i am saying that because one of the local pharmaceutical companies in the middle east recently started exporting some of their production to germany???

    cheers
    [COLOR=Olive]xxxx They tried to break my back, but i survived. whatever doesn't kill you, will only makes you stronger xxxx
    [/COLOR]

  • #2
    Re: rules regarding importing drugs from outside the EU??

    Originally posted by Ray View Post
    heya
    i am not quite sure about the movement of drugs internationally. i understand someone can apply for importing license to import some cheaper products from the EU, what about from non-EU countries?

    i am saying that because one of the local pharmaceutical companies in the middle east recently started exporting some of their production to germany???

    cheers
    If its licensed and regulated this is the usual way. Many drugs are made primarily in one or two locations and especially for drugs with a small global consumption may have only two batches made annually in the whole world so of course imports are essential whether into the EU or out of the EU.

    One country (admittedly outside the EU) I know imports most of their drugs from the generics companies in India. For a product to get a license apart from evaluation of the product the actual factories must be inspected. If the factory fails to meet the standards of the importing country(quality control, equipment cleanliness, staff training, record keeping etc) no products made in that factory can be used in the importing country. Of course there is the potential for counterfeiting and supplying batches from a non approved premises purporting to be from the approved premises but if the company were caught the product licences would be revoked.

    In addition most regulatory authorities carry out spot checks. Some even check every batch enntering the country, however this is not always economically practical.

    In my limited experiance the UK/EU is very similar but you can find more details on the MHRA website. I should imagine that the majority of Europe's medicines are made in countries with cheaper labour, particularly those in Asia and Eastern europe including Russia.
    Last edited by paul2008; 3, September 2008, 04:34 PM. Reason: spilling
    Real stupidity beats artificial intelligence every time.
    (T. Pratchett)

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    • #3
      Re: rules regarding importing drugs from outside the EU??

      All this came up about 30 years ago when quality assurance began to replace quality control.

      Quality Control(QC) was did the finished product meet BP standards?

      Some factories in 3rd world had beaten earth floors and electricity was often cut. I saw one batch of granules from a dryer which had lost power and moulds had grown very quickly.

      Quality assurance(QA) looked at the whole process from raw material to finished product. Ie products had to be produced in properly equipped factories which were clean and pest free. (In one factory I saw frogs hopping around the computers which had 'died' when the power went off. Several workers were asleep.)

      johnep

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