GACETA OFICIAL 5921 PDF

Diario de la Marina (22 November ): 1. Valdés, Geronimo. Gaceta Oficial de la República de Cuba (18 March ): – ———. entitled “An Act Regulating the Practice of Pharmacy and Setting following the full and complete publication thereof in the Official Gazette or in any. New Zealand Official Crest Notice Number. ds Official Crest. The New Zealand Gazette is published by the.

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Pursuant to the attainment of this general policy, an effective competition policy in the supply and demand of quality affordable drugs and medicines is recognized by the State as a primary instrument.

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 oficia of the means to also promote and ensure access to quality affordable medicines. Construction in Favor of Protection of Public Health. Multisource pharmaceutical products that are therapeutically equivalent are interchangeable.

Section 22 of Republic Act No. Discoveries, scientific theories and mathematical methods, and in the case of drugs and medicines, 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.

Section 26 of Republic Act No. An invention involves an inventive step if, having regard to prior art, it is not obvious to a person skilled in the art at the time of the filing date or priority date of the application claiming ovicial invention.

Presidential Decree No. , s. | Official Gazette of the Republic of the Philippines

In the case of gacceta and medicines, there is no inventive step if the invention results from the mere discovery ooficial 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.

Section 72 of Republic Act No. Limitations of Patent Rights. Using a patented product which has been put on the market gacsta the Philippines gacfta the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market: 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: Provided, furtherThat the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any private third party.

Where the act is done privately and on a non-commercial scale or for a non-commercial purpose: ProvidedThat it does not significantly prejudice the economic interests of the owner of the patent.

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 oficiql educational gaceeta use. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or gceta another country that regulates the manufacture, construction, use or sale of any product: ProvidedThat, in order to protect the data submitted oficia the original patent holder from unfair commercial use provided in Article Where the act consists of 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.

ProvidedThat such invention is used exclusively for the needs of the oficila, vessel, aircraft, or land vehicle and not used for the manufacturing of anything to be sold within the Philippines.

Section 74 of Republic Act No. Use of Invention by Government. A Government agency or third person authorized by the Government may exploit the invention even without agreement of the patent owner where:. Unless otherwise provided herein, the use by the Government, or third person authorized by the Government shall be subject, where applicable, to the following provisions:. ProvidedThat, 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.

All cases arising from the implementation of this provision shall be cognizable by courts with appropriate jurisdiction provided by law. The Intellectual Property Office IPOin consultation with the appropriate government agencies, shall issue the appropriate implementing rules and regulations for the use or exploitation of patented inventions as contemplated in this section within one hundred twenty days after the effectivity of this law. Civil Action for Infringement.

The making, using, offering for sale, selling, or importing a patented product or a product obtained directly or indirectly from a patented process, or the use of a patented process without the authorization of the patentee constitutes patent infringement: ProvidedThat, this shall not apply to instances covered by Sections Section 93 of Republic Act No. Grounds for Compulsory Licensing. National emergency or other circumstances of extreme urgency.

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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. Where a judicial or administrative body has determined that the manner of exploitation by the owner of the patent or his licensee is anti-competitive; or.

In case of public non-commercial use of the patent by the patentee, without satisfactory reason. If the patented invention is not being worked in the Philippines on a commercial scale, although capable of being worked, without satisfactory reason: ProvidedThat the importation of the patented article shall constitute working or using the patent; Secs.

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. The Director General of the Intellectual Property Office, upon the written recommendation of the Secretary of the Department of Health, shall, upon filing of a petition, grant a special compulsory license for the importation of patented drugs and medicines.

The special compulsory license for the importation contemplated under this provision shall be an additional special alternative procedure to ensure access to quality affordable medicines and shall be primarily for domestic consumption: ProvidedThat adequate remuneration shall be paid to the patent owner either by the exporting or importing country. 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.

A compulsory license shall also be available for the manufacture and export of drugs and medicines to any country having insufficient or no manufacturing capacity in the pharmaceutical sector to address public health problems: 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.

The right to grant a special compulsory license under this section shall not limit or prejudice the rights, obligations and flexibilities provided under the TRIPS Agreement and under Philippine laws, particularly Section It is also without prejudice to the extent to which drugs and medicines produced under a compulsory license can be exported as allowed in the TRIPS Agreement and applicable laws. Section 94 of Republic Act No. Period for Filing a Petition for a Compulsory License.

A compulsory license may not be applied for on the ground stated in Subsection A compulsory license which is applied for on any of the grounds stated in Subsections Section 95 of Republic Act No. The license will only be granted after the petitioner has made efforts to obtain authorization from the patent owner on reasonable commercial terms and conditions but such efforts have not been successful within a reasonable period of time.

The requirement under Subsection In situations of national emergency or other circumstances of extreme urgency, the right holder shall be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly.

Where the demand for the patented drugs and medicines in the Philippines is not being met to an adequate extent and on reasonable terms, as determined by the Secretary of the Department of Health, the right holder shall be informed promptly.

Section of Republic Act No. Except in cases of importation of drugs and medicines allowed under Section 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.

Limitations to Actions for Infringement. ProvidedThat said drugs and medicines bear the registered gacetx that have not been tampered, unlawfully modified, or infringed upon as defined under Section of this Code. 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. No court, except the Supreme Court of the Philippines, shall issue any temporary restraining order or preliminary injunction or preliminary mandatory injunction that will prevent the immediate execution of the exercise of this power of the President of the Philippines.

The Secretary of the Department of Health may also create such bodies, consultative councils, from which advice may be sought in the implementation of a drug or medicine price monitoring and regulation policy. Such bodies or consultative councils created by the Secretary of the Department of Health shall coordinate its efforts together with other government agencies. Functions and Responsibilities of the Secretary of the Department of Health. 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 gacera determine the maximum retail prices of drugs and medicines which shall be recommended to the President of the Philippines for approval.

B Power to Include Other Drugs and Medicines in the List Subject to Price 5291 — Upon application or motu proprio when the public interest so requires and after proper determination, the Secretary of gacetw Department of Health may order the inclusion of drugs and medicines to the list subject of price regulation under Section 23 hereof.

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.

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D Power to Impose Administrative Fines and Penalties — After due notice and hearing, the Secretary of the Oricial 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, E Power to Deputize Government Entities — The Secretary of the Department of Health shall have the power to call upon 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.

F Other Powers Necessary to Implement Provisions of this Chapter — Oficoal Secretary of the Department of Health shall exercise such powers and functions as may be necessary to implement and enforce the provisions of this Chapter gacea this Act, including the power to require the production and submission of records, documents, books of account, bills of lading, input documents, records of purchase and sale, financial statements, and such other documents, information and papers as may be necessary to enable the Secretary of the Department of Health to carry out its functions, duties, and responsibilities.

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 521 price regulation shall furnish the Secretary of the Department faceta Health a gaecta, 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.

The filing of a petition for oficiap writ of certiorari or other special remedies in the Supreme Court shall in no case supersede or stay any decision, order or ruling of the Secretary of the Department of Health, unless the Supreme Court shall so direct, and the petitioner may be required by the Supreme Court to give bond in such form and of such amount as may be deemed proper. Illegal Acts of Price Manipulation.

Republic Act No. 9502

Penalty for Illegal Acts of Price Manipulation. The court may also order the suspension or revocation of its gacefa to operate LTOprofessional or business license.

Whenever any act of illegal price manipulation of any drug oficual medicine subject to price regulation is committed by a juridical person, its officials or employees, or in case of a foreign corporation or association, its agent or representative in the Philippines who are responsible for the violation, shall be held liable therefor. ProvidedThat it conforms to existing drug product labeling requirements, every manufacturer, importer, distributor, wholesaler, trader, or retailer of a drug and medicine intended for sale shall display the retail price which shall not exceed the maximum retail price approved by order of the President of the Philippines.

The DTI shall always officially provide the Secretary of the Department of Health copies of these independent reports. Reportorial and Public Notice Requirements. This report submitted to the Office of the President shall be published in a newspaper of general circulation within thirty 30 days upon submission.

It shall also regularly report and comply immediately to any order of the Congressional Oversight Committee. All wholesalers, manufacturers, distributors, importers, or traders shall have a copy of the order of the President of the Philippines and provide the same to their clients and customers for every transaction.

This amount, which shall be in addition to the annual budget of the Bureau of Food and Drugs, shall be deposited and maintained in a separate account or fund, which may be used or disbursed directly by the Director or head. 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 gacsta 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.

The report shall itemize the use of such retained funds in the past year up to the present and the budgeted use of the same in the succeeding periods. Quality Assurance of Drugs. ProvidedThat imported products in finished dosage forms, should be certified under the World Health Organization WHO certification scheme on the quality of pharmaceutical products moving in international commerce: Provided, furtherThat the registration for multisource pharmaceutical products should conform to the WHO guidelines on registration requirements to establish interchangeability.

For this purpose, the said products shall be displayed with equal prominence as all other products sold in the establishment. Refusal to Sell Drugs and Medicines. For the succeeding offense, the penalties shall not be less than Five hundred thousand pesos Gceta, Section 5 of Gacetq Act No. Section 6 of Republic Act No. Who Shall Use Generic Terminology.