GACETA OFICIAL 5921 PDF

Terg Quality Assurance of Drugs. Section 11 of Republic Act No. ProvidedThat, said drugs and medicines bear the registered marks that have not been tampered, unlawfully modified, or infringed upon, under Section of this Code. If the patented invention is not being worked in the Philippines on a commercial scale, although capable of being worked, without satisfactory reason: ProvidedThat, with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention: ProvidedThat the importation of the patented article shall constitute working or using the patent; Secs. Presidential Decree No. Learn more about the Philippine government, its structure, how government works and the people behind it.

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Daihn In the event that full competition is not effective, the State recognizes as a reserve instrument the regulation of prices of drugs and medicines, with clear accountability by the implementing authority as mandated in this Act, as one of the means to also promote and ensure access to quality affordable medicines. Republic Act No. Section 25 of Republic Act No. Where the act consists ggaceta the preparation for individual cases, in a pharmacy or by a medical professional, of a medicine in accordance with a medical prescription or acts concerning the medicine so prepared; and.

Section gacta of Republic Act No. The court may also order the suspension or revocation of its license to operate LTOprofessional or business license. The Department of Health with the assistance of the Department of the Interior and Local Government and the Philippine Information Agency shall monitor the progress of the education drive, and shall submit regular reports to Congress.

E Power to Deputize Government Entities — The Secretary of the Department of Health shall have the power to call oficiak and deputize any official, agent, employee, agency, or instrumentality of the national and local government for any assistance that it may deem necessary to carry out the purposes of this Chapter.

Refusal to Sell Drugs and Medicines. If the vaceta invention is not being worked in the Philippines on a commercial scale, although capable of being worked, without satisfactory reason: C Power to Implement Cost-Containment and Other Measures — 1 The Secretary of the Department of Health shall have the power oficil implement the fair price of drugs and medicines for purposes of public health insurance and government procurement based on the order of the President of the Philippines imposing maximum retail prices; and.

For the succeeding offense, penalties shall not be less than Five hundred thousand pesos Php, It shall also regularly report and comply immediately to any order of the Congressional Oversight Committee. Section 8 of Republic Act No. Where the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the appropriate agency of the Government, so requires; or.

Sale of medicine, pharmaceuticals, drugs and devices. GaxetaThat, the Government or third person authorized by the Government, without making a patent search, knows or has demonstrable ground to know that a valid patent is or will be used by or for the Government. Where the demand for patented drugs and medicines is not being met to an adequate extent and on reasonable terms, as determined by the Secretary of the Department of Health.

Discoveries, scientific theories and mathematical methods, and in the case of drugs and medicines, the mere discovery gacta a new form or new property of a known oficil which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process unless such ocicial process results in a new product that employs at least one new reactant.

Illegal Acts of Price Manipulation. Non-prescription or over-the-counter drugs may be sold in their original packages, bottles, containers or in small quantities, not in their original containers to the consuming public through supermarkets, convenience stores and other retail establishments. Presidential Decree No. Official Gazette of the Republic of the Philippines C Power to Implement Cost-Containment and Other Measures — 1 The Secretary of the Department of Health shall have the power to implement the fair price of drugs and medicines for purposes of public health insurance and government procurement based on the order of the President of the Philippines imposing maximum retail prices; and 2 The Secretary of the Department of Health shall have the power to implement any other measures that the government may avail of to effectively reduce the cost of drugs and medicines that shall include, but not limited to, competitive bidding, price volume negotiations, and other appropriate mechanisms that influence supply, demand and expenditures on drugs and medicines.

The power to impose maximum retail prices over drugs and medicines shall be exercised within such period of time as the situation may warrant as determined by the President of the Philippines. ProvidedThat said drugs and medicines bear the registered marks that have not been tampered, unlawfully modified, or infringed upon as defined under Section of this Code. Civil Action for Infringement.

Reportorial and Public Notice Requirements. Functions and Responsibilities of the Secretary of the Department of Health. Quality Assurance of Drugs. The compulsory license shall also contain a provision directing the grantee the license to exercise reasonable measures to prevent the re-exportation of the products imported under this provision. D Power to Impose Administrative Fines and Penalties — After due notice and hearing, the Secretary of the Department of Health shall have the power to impose administrative fines against any person, manufacturer, importer, trader, distributor, wholesaler, retailer, or any other entity, in such amount as it may deem reasonable, which in no case shall be less than Fifty thousand pesos Php50, In the case of brand name products, the generic name shall appear prominently and immediately above the brand name in all product labels as well as in advertising and other promotional materials.

Who Shall Use Generic Terminology. Official Gazette Open Data Portal. Accordingly, within thirty 30 days from the effectivity of this Act and every December 31st of every year thereafter, every manufacturer, importer, trader, distributor, wholesaler, and retailer of a drug and medicine whether included in or excluded from the list of drugs and medicines that are subject to price regulation shall furnish the Secretary of the Department of Health a list, containing on the minimum the corresponding prices and inventory, of all drugs and medicines it manufactures, imports, trades, distributes, wholesales, or retails, data pertaining to the factors enumerated under Section 19 A 2and any and all necessary information that the Secretary of the Department of Health may require.

In case of the use of an identical sign for identical goods or services, a likelihood of confusion shall be presumed. ProvidedThat, said drugs and medicines bear the registered marks that have not been tampered, unlawfully modified, or infringed upon, under Section of this Code. Within one 1 year after the approval of this Act, the drug outlets referred to herein shall post in conspicuous places in their establishments a list of drug products with the same generic name and their corresponding prices.

Section 22 of Republic Act No. Period for Filing a Petition for a Compulsory License. A compulsory license which is applied for on any of the grounds stated in Subsections B Power to Include Other Drugs and Medicines in the List Subject to Price Regulation — Upon application or motu proprio when the public interest so requires and after proper determination, the Secretary of the Department of Health may order the inclusion of drugs and medicines to the list subject of price regulation under Section 23 hereof.

In the case of drugs and medicines, there is no inventive step if the invention results from the mere discovery of a new form or new property of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process unless such known process results in a new product that employs at least one new reactant.

Where the act consists of making or using exclusively for experimental use of the invention for scientific purposes or educational purposes and such other activities directly related to such scientific or educational experimental use. A Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to Price Regulation — 1 Upon application or motu proprio when the public interest so requires, the Secretary of the Department of Health shall have the power to determine the maximum retail prices of drugs and medicines which shall be recommended to the President of the Philippines for approval.

If so, it shall retain all the fees and charges it shall collect under the same conditions indicated in said Subsection a but shall forthwith, cease to receive any funds from the annual budget of the National Government; if not, the provisions of Subsection a shall continue to apply until such time when the Director or head of the Bureau of Food and Drugs, subject to the approval of the Secretary of the Department of Health, certifies that the abovestated fees and charges the Bureau of Food and Drugs shall collect are enough to fund its operations.

This Act which is a consolidation of Senate Bill No. Section 74 of Republic Act No. ProvidedThat, a compulsory license has been granted by such country or such country has, by notification or otherwise, allowed importation into its jurisdiction of the patented drugs and medicines from the Philippines in compliance with the TRIPS Agreement.

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