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Which medicines can be notified – and which must be assessed by NOMA before dispensing?

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    Most applications for compassionate use, named patient can be dispensed directly by the pharmacy (notifiable) without prior approval from NOMA. 

    Medicines That Can Be Notified 

    • Medicines that have marketing authorisation in the EEA area, in countries that are members of PIC/S, and countries with an MRA agreement.
    • Products considered as medicines in Norway, but produced and marketed as foodstuffs in EEA countries, Canada, or the USA.
    • Products listed on the dispensing list (formerly called the "positive list"). These are medicines that, according to the main rules, should be assessed by NOMA before dispensing but can still be notified by the pharmacy. 

    Medicines Whose Applications for Compassionate Use, Named Patient Must Be Assessed by NOMA Before Dispensing (Negative list) 

    • Medicines (including foreign pharmacy-compounded medicines) that do not have marketing authorisation in the EEA, PIC/S countries, or countries with an MRA agreement.
    • Medical gases.
    • Other listed medicines - see the negative list. 

    Countries in the EEA Area or PIC/S (Pharmaceutical Inspection Cooperation Scheme) 

    Argentina, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Greece, Hong Kong, Indonesia, Iran, Ireland, Iceland, Israel, Italy, Japan, South Korea, Croatia, Cyprus, Latvia, Liechtenstein, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, South Africa, Taiwan, Thailand, Czech Republic, Turkey, Germany, Ukraine, Hungary, USA, Austria. 

    Countries with MRA Agreement (Mutual Recognition Agreement) 

    New Zealand, Australia, Canada, and Switzerland.