欧美性猛交XXXX免费看蜜桃,成人网18免费韩国,亚洲国产成人精品区综合,欧美日韩一区二区三区高清不卡,亚洲综合一区二区精品久久

Ukraine's president Victor Yanukovych has ratified an amendment to Article 9 of the country's Law on Medicines, which introduces a number of important changes to the regulations regarding the registration of originator and generic pharmaceutical products, and the associated data exclusivity regulations, reports Ukrainian pharmaceutical news provider Apteka.ua. The changes came into force on 30 November.

Main Aspects of Law Amendment

As a result of the changes, the following regulations now apply in Ukraine, as reported by Apteka.ua:

• In the case of a new originator medicine registered in Ukraine for the first time, a generic version may not be registered less than five years after the date of the registration of the originator; this rule only applies if the originator has been registered in Ukraine no later than two years after its first registration in any other market.
• The five-year data-exclusivity period can be extended to six years if during the first three years after the originator medicine's registration it has its use extended to another indication for which the drug has an advantage over existing ones; the regulations and criteria regarding this are to be established in a decree of the Ukrainian Ministry of Health (MoH).
• In certain cases, the prohibition of registering a generic version does not apply:

• if the manufacturer of the originator gives the generic producer the right to refer to and use information relating to the originator
• if the applicant registering a generic version files a complete registration that meets the level of the originator drug's information

• Generics producers applying to register generic versions of originators may do so before the end of the five-year data-exclusivity period, making it possible for them to gain a registration certificate on the completion of the five-year period.
• The producer of the originator will lose exclusivity if they fail to register their product in Ukraine within two years of its first registration in another market.

Compulsory Licensing Consolidated

Additionally, the law amendment also solidifies the practice of compulsory licensing in Ukraine, Apteka.ua reports, quoting the section stating that in order to ensure public health, the Ukrainian government may authorise the use of a patented invention without the agreement of the patentee, if the latter does not agree to issue a licence. The source emphasises that compulsory licensing is not a new practice in Ukraine.

Confusion over GMP Application

Companies applying for marketing approval for their medicines in Ukraine must also present a copy of a document that confirms their compliance with regulations regarding the production of medicines in Ukraine. Such documents will be issued by the State Administration of Ukraine on Medicinal Products. It is questioned how this will function in connection with the accession of the State Administration to the Pharmaceutical Inspection Co-operation System (PIC/S), because in the law amendment there is no provision for applicants to submit certificates confirming compliance with Good Manufacturing Practice (GMP), even in the case of products made in countries that are part of the PIC/S system.

Law Amendment Designed to Increase Access

Olga Baula, a quality-assurance consultant for medicines with public health programmes in Ukraine, is quoted by Apteka.ua as saying, after the law amendment was passed by the Ukrainian parliament, that the amendment is intended to promote increased access to medicines, and is in response to an increase in spending on medicines brought about by the "monopolisation" of certain areas of the market by innovative companies. She is reported as saying that, in the past four years, since the previous amendment to Article 9 of the Law on Medicines was introduced, over 200 medicines had enjoyed market exclusivity in Ukraine, commanding high prices, and blocking the timely entry of cheaper generic alternatives. She particularly focuses on medicines to treat HIV/AIDS, giving examples of medicines that have long-term patent protection.

Outlook and Implications

The new amendment to Ukraine's Law on Medicines is presented as balancing the requirement to protect data exclusivity on the one hand, and to promote enhanced access to medicines for Ukrainians on the other. Although the original amendment to the Law is seen as giving too much away to innovative producers, the new amendment provides the "stick" as well as the "carrot": companies will be forced to consider entering the Ukrainian market earlier than they might have planned—if they had planned to enter it at all—in light of the fact that if they fail to do so within two years of their product first being registered, they will forfeit their right to data exclusivity in Ukraine.

This provision, as well as the "confirmation" of the legal status of compulsory licensing, is consistent with the agenda of increased access to medicines in Ukraine, and also with the government's aim of increasing the proportion of medicines consumed in Ukraine that are produced in the country.

For innovative pharmaceutical companies, these are negative, if not entirely surprising, developments. Ukraine remains an important market, due to its sheer size and potential, although it is set to remain a challenging one for the foreseeable future.