Upharmacia January 2017
REGULATORY UPDATES JANUARY 2017
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Simplified Drug Registration Came Into Force
On Jan 3 , 2017 , the Ministry of Justice of Ukraine has registered the order of the MOH on launch of the mechanism on simplified registration of medicines registered in countries with strong regulatory authorities .
The new mechanism provides for the simplified registration of medicinal products being registered by the competent authorities of the USA , Switzerland , Japan , Australia , Canada , and the European Union in accordance with the centralized procedure .
Such products should be accepted for usage in the territories of the mentioned countries or the EU member-states .
The registration procedure for such medicinal products envisages the submission of the smaller package of documents , reduction of registration terms ( 17 business days ), and no need for the expertize of the registration materials .
New Procedure for Calculating Maximum Gross Wholesale Prices for Medicinal Products on the Basis of Reference Prices
On Dec 29 , 2016 , in pursuance of Resolution of the Cabinet of Ministers of Ukraine " On State Regulation of Prices for Medicinal Products " No . 862 , the Ministry of Health of Ukraine adopted Order No . 1423 , thereby approving the Procedure for Calculating Maximum Gross Wholesale Prices for Medicinal Products on the basis of Reference Prices ( hereinafter - the Procedure ).
The Procedure was officially published and came into force on Jan 6th , 2017 . The Procedure applies to medicinal products used in treatment of cardiovascular diseases , diabetes of type II and bronchial asthma , the cost of which is refundable in accordance with Resolution of the Cabinet of Ministers of Ukraine No . 863 as of Nov 9 , 2016 ( 21 INNs in total ).
As its name implies , the Procedure establishes a mechanism for calculating maximum gross wholesale prices for medicinal products on the basis of reference prices .
The latter are determined in UAH ( reference prices in foreign currencies are denominated in UAH at the official NBU rate as of the date of determination of prices ), taking into account the data on registered prices for medicinal products ( of each dosage form ) obtained from official sources of the authorized public authorities of the following reference countries : the Republic of Poland , the Slovak Republic , the Czech Republic , the Republic of Latvia and Hungary .
Maximum gross wholesale price of a single dosage form of a medicinal product from among 21 INPN is calculated as the smallest reference price of a unit of each dosage sample values of the respective reference prices in the countries using the following algorithm :
MGWP = MIN ( RP1 ... RPN ),
Where MGWP – maximum gross wholesale price ;
RP1 RPN - reference prices in the reference countries .
New Procedure for Pharmacovigilance
A new Procedure for Pharmacovigilance approved by Order of the Ministry of Health of Ukraine No . 898 as of Dec 27 , 2016 ( hereinafter - the Procedure ) entered into effect on Jan 6 , 2017 .
In addition to significant additions and changes to the terminology , the new Procedure also specifies new requirements to the applicant ' s
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