Annex 4. Application of Article 23: Wholesalers to decommission on behalf of persons authorised or entitled to supply medicines to the public

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1 Annex 4. Applicati Article 23: Wholesalers to decommissi behalf perss authorised or entitled to medicines to the public Perss retailers Den emergency other AT BE Yes, for to emergency supplies ships Vaccinati centres : Adopti expected Q3 - beginning Q4. BG CY CZ : all DE Yes, in principle possible, but natial law restricted to, included Yes, in principle possible, but natial law restricted to Yes, in principle possible, but natial law restricted to Vaccines Adopti the Amendment the Act Pharmaceutica ls expected in Q (applies to t al maintaining stocks for the civil protecti disaster ctrol) (applies to universities other using for the ) Yes, natial legislati has been, is in force since 13 July 2018

2 retailers Den emergency other DK EE EL ES Yes, ly for some Yes, ly for some FI for use Yes, ly for some Yes, except medicin al supplied to military pharmac ies Government al for civil protecti (e.g. vaccinati programmes ) for, Royal Decree currently. Adopti t at this time, expected later this year FR yes yes yes no Yes no yes yes yes no no no yes, adopti HR Vaccinati centres: for Yes all, if there is no pharmac y in g the medicin es to pris, currently. Final decisi will be made by the Ministry Health.

3 retailers Den emergency other HU IE IT, currently adopti Discussi is going natially to agree what entities fall the definiti a healthcare instituti as defined in the Delegated Regulati prior to publishing natial legislati. LT Yes, ly legal entities, providing the following types healthcare services: health rehabilitati; family medicine (general ); forensic Vaccinati centres: Exempti applies ly to used natial immunopro phylaxis programme for Approval the Order the Minister Health is expected 31/10/2018

4 retailers Den emergency other LU LV medicine The exempti applies to a very small amount that are used for healthcare in these legal entities, such as just first aid kits others as needed. Yes, depending a list supplied to Ministry Yes, example general in private practice, if decommissi ing is not de by them N.A. ( cascade: human are decommissi ed by ) MT Yes, but ly for anaesthetics Yes, ly anaesthetics N.A. Yes, but reserved to () Yes, but reserved to Yes, for the purpose s civil protecti disaster ctrol Yes, for the purpose s civil protecti disaster ctrol Yes, based special lists Yes, for the civil protecti disaster ctrol for for for currently (State council) Yes, ly, currently adopti, currently

5 retailers Den emergency other NL Yes Yes Yes, where not via a pharmac y PL, currently. (This is a ccept subject to change) PT Yes NA Yes Yes Yes Yes Yes Yes Yes Yes NA Yes Yes Legislati published 24 April 2018 Additially, INFARMED, I.P. is preparing a directory listing all entities behalf whom wholesalers have to verify. This Directory will be made public, ce available, to everybody in the circuit. RO Yes for dialysis centres (until ) for units performing clinical studies Yes Yes, unless they have a pharmacy in their structure Yes (until ) Yes ( until ) Yes, Ministry Health Order no. 985/

6 retailers Den emergency other SE All SI SK UK All All, currently adopti, currently adopti expected - decisi planned Q4, our intenti is to ensure that the would be as smooth as possible "vulnerable" chains burdened as little as possible, wholesalers can expect to be respsible for decommissi ing (reg. art. 23) NO Yes, partly as wholesalers can sell Yes Yes Yes, medicines supplied for technical (n- Yes Yes, but stakeholders have been

7 retailers Den emergency other medicines to pet owners, but is to veterinarians. ) use informed the proposals.