Upharmacia July 2017
applicant ' s changes to the registration dossier in the country of registration due to the lack of such information in public access in some countries ;
• Incorrect translation of instructions to the drug , which is given in an arbitrary form and does not require notarization .
The Ministry of Health Has Proposed to Expand the Orphan Diseases List
On June 29 , 2017 , the Ministry of Health of Ukraine published the draft order of the Ministry of Health of Ukraine " On introducing changes to the list of rare ( orphan ) diseases leading to a reduction in the life expectancy of patients or their disability and for which there are recognized methods of treatment ." on the website for public discussion .
The draft proposed to complete the current list of orphan diseases with new nosologies , and to expand the list of orphan diseases indices according to the Orphanet portal system for individual nosologies . In particular , it was proposed to add to " Rare endocrine diseases , nutritional disorders and metabolic disorders " section the following items :
• impaired ornithine metabolism . Argininemia . Ornithine transcarbamylase deficiency ;
• glycine imbalance ;
• other disorders of lipid accumulation . Wolman ' s disease ;
• hereditary erythropoietic porphyria ;
• porphyria cutaneous tarda ;
• other porphyria ;
• lipomatosis , not elsewhere classified .
In addition , section IV " Rare diseases of the nervous system " is recommended to be completed with the following nosologies :
• encephalitis , myelitis and encephalomyelitis . Encephalitis , myelitis and encephalomyelitis in diseases classified elsewhere . Progressive encephalomyelitis with rigidity and myoclonus ;
• secondary parkinsonism , caused by other external factors ;
• other forms of secondary parkinsonism ;
• blepharospasm ;
• dystonia , unspecified ;
• hereditary motor and sensory neuropathy .
Also , the Ministry of Health proposes to introduce a new section of orphan diseases , namely : Section XI " Rare diseases of sclera , cornea , iris and ciliary body ", including Interstitial ( stromal ) and deep keratitis ( Kogan syndrome ).
The National List of Essential Medicines Enactment Has Been
Postponed Until September 1 , 2017
On July 4 , 2017 , the government adopted resolution " On Amendments to Cabinet of Ministers Decree No . 333 of March 25 , 2009 ", the draft of which is posted on the official website of the Ministry of Health of Ukraine for public discussion .
The document provides for postponing the date from which health institutions funded from state and local budgets should launch government purchases of medicines registered in Ukraine and included in the National List of Essential Medicines until September 1 , 2017 .
In addition , the draft decree of Cabinet of Ministers of Ukraine provides for postponing the enactment of the provision on the obligation of customers to pre-satisfy in full the requirements for medicines registered in Ukraine and included in the National List of Essential Medicines until January 1 , 2018 .
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