Once approved, the agency will schedule a site inspection. (d) one pharmacist, to be nominated by the Federal Government; Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. 6.10.2 Disposal Powers of Registration Board: The members of the Registration Board shall exercise all the powers of Inspector without restriction as the area, and shall have the powers of a Provincial Inspector in relation to Section 30. SECTION-I (2) They shall come into force at once. Personnel 34. Dosage from of the drug: Zinc Sulphate. (iii) licence to manufacture by way of formulation; (c) infants. Labelling : Specimen or draft with colour scheme, alongwith the undertaking to refrain from counterfeiting shall also be submitted. Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; 1. Signature of the Analyst. (7-A) The indenter, importer or manufacturer's authorised agent shall issue a warranty in Form 2-A for any drug indented or sold by him for the purpose of re-sale or distribution; and 10. or the director or manager of the firm or company by which, the drug will be manufactured. Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. Sign in to start your session. (9) No drug or any other substance shall be advertised in a manner which encourages self-medication or use to the extent that it endangers health. 4.8.1 Written programme Sodium Potassium Tartrate. 7. PROFORMA VALUE (in Rs.) (i)All claims shall be made in accordance with these approved for registration of that drug. Signature of the expert staff responsible for manufacture. Description of bill of sale, invoice, bill of lading or other document (if any). (2) No person who is a member of the Appellate Board shall be nominated to the Central Licensing Board. Bioburden to be minimal 8. Test Report number. There have been/have not been any change in respect of 1. Equipment maintenance 10. 60. The following equipment required :- 6.10.1 Storage Weight of granules. Weight of each rabbit. (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: (2) Kettles, steam, gas or electrically heated. SECTION -- 5 (4) The Central Licensing Board may co-opt any other person who is expert in the pharmaceutical or medical profession for advice on any particular matter under consideration. Free samples of non-prescription drugs to the general public for promotional purposes.- There shall be no free sampling of non-prescription drug to the general public for promotional purposes. license by examination or by license transfer the applicants who are qualified to engage in the practice of . DETAILS OF THE FIRM 17. The importation into Panama of narcotic, controlled and restricted drugs is subject to import licensing to ensure that traders' procedures are in conformity with Panama's international obligations (Single Convention on Narcotic Drugs 1961 and Convention on Psychotropic Substances 1981). (am) "quality control" means the part of good manufacturing practices concerned with sampling, specifications, and testing as well as the organization, documentation, and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor finished products released for sale or supply until their quality has been judged to be satisfactory and it is involved in all decisions concerning the quality of the product; Licensing Authority. 68. 5. Find funding 5. 9. 4. Calcium Hydroxide. B. Parenteral preparation: HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. The drug(s) or class(es)of drugs intended to be continued to be manufactured:- Ammonium Carbonate. (10) The Licensee shall, on demand, furnish to the Central Licensing Board or the Provincial Quality Control Board or to such authority as the Central Licensing Board may direct, from every batch of a drug, or from such batch or batches of drugs as it may from time to time specify, a sample for examination and, if required, furnish full Protocols of the tests which have been applied. 4. (4) The Registration Board may appoint a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit its report to the Board. is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- Monitoring water supply of sources (i) enclose certificate of registration and Free Sale from any of the following countries: Examination Procedure: 1. 18. (d) any directions for the use to be included in the labelling, warning and precautions in use : symptoms of over dosage should be given alongwith the treatment including antidotes, where required. 12,500 (8) The Central Licensing Board shall follow such policy directing as the Federal Government may issue from time to time. The NAPLEX is one component of the licensure process required to practice as a pharmacist. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG 6. Value of raw materials used (Active & inactive) (in Rs.) Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. FORM 6 Introduction . Packaging and labelling.- Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material shall provide information consistent with that approved by the Registration Board and if no such approval is available it shall be, consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. 3.7.3 Written procedures Name of the sample. Duration of the exam is 2 hours 3. Potassium Bromide. 6.6.1 Storage and disposal (a) The applicant shall provide premises which shall be suitable for intended use, in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination. Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. 9. Ammonium Bicarbonate. Graduates Pharmacist Collaborative Practice Certification Procedure to Follow When Applying for a License to Sell Drugs 1) Complete the form-5 that is mandated in the Drug Rules. Promotion of drugs.- (1) For the purposes of this Schedule, "promotion" means all informational and persuasive activities by manufacturer and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. 8. Although health education aimed at children is highly desirable, drug advertisements shall not be directed at children. (4) If the application for renewal of registration is made after the expiry of the period of the validity of the certificate or registration, it shall be treated as a fresh application for the registration of drug. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. (Seal) Chairman, Central Licensing Board. Protocols of tests applied: 28. 2. SECTION -- 3 Conditions for grant or renewal of a licence to manufacture drugs by way of basic or semi-basic manufacture: (1) Before a licence to manufacture by way of basic or semi-basic manufacture is granted or rehewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- (9) No act or proceeding of the Central Licensing Board shall be invalid merely on the ground of the existence of any vacancy in, or any defect in the constitution of the Board. 2.3 Products sterilized by filtration 27. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate 4.4 Quarantine (8) Hot Air Steriliser, (ii) Others A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . Cancellation or suspension of licences: (1) If licensee does not comply with any of the conditions of a licence or violates any of the provisions of the Ordinance or the rules, or fails to deposit the requisite amount of the Central Research Fund due from him, the Central Licensing Board may, by an order in writing stating the reasons thereof, cancel a licence or suspend it for such period as it thinks fit, either wholly or in respect of some of the drugs to which it relates. 24 may be advertised to the medical, pharmaceutical and allied professions, without referring to the Federal Government, through medical representatives or through professional journals and publication which are meant for circulation exclusively amongst the members of the medical, pharmaceutical and allied professions SECTION -- 7 Substances Parenteral preparation in general: Renewal of a licence: On application being made for renewal, the Central Licensing Board may cause an inspection to be made, and if satisfied that the conditions of the licence and the rules are and will continue to be observed, shall issue a certificate of renewal or otherwise reject the application and inform the licencee accordingly. (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); 20. (ii) Tableting Section; (f) the applicant shall ensure that-- (1) Class(es) of drugs. 40. (i) A decease of more than 20% in blood cholinesterase activity,. 1. (13) No drug manufactured under licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. (a) recommended clinical use and the claim to be made for the drug. 7. (3) Sealing equipment, The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. sub-rule (8); and (4) Tube filling equipment. 7.4.10 Discrepancies to be investigated Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. 3.2 Services (1) Tablet machine, single punch or rotary. SECTION--2 2.6 Filters 3. Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. Benzoic Acid. 2.4 Piping 2.1 Manufacturing operations Name and address of the manufacturer: 15. (i) the claims to be made for the drug; (b) contra-indications. (I) The following equipment is required for the manufacture of inhalers end Vitrallae: (3-A) Application for renewal of registration of a drug shall be made in Form 5-B. 3.4.4 Frequency of self inspection (c) experiences, investigations, studies and tests involving the chemical or physical properties or any other properties of that drug; Calculated Paid investment Turnover (x) "large-volume parenterals" means sterile solutions intended for parenteral application with a volume of more than 100ml in one container of the finished dosage form; Household remedies including-- Salicylic Acid. Processing 2. Researching legal requirements is an important step in learning how to open a pharmacy, and you want to ensure that you have everything properly set-up before opening your business. 2, Name of drug Test Report number. Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding. For the quarter ending. It is compulsory to pass the DHA exam in order to practice as a licensed medical professional in Dubai. Dated (Signed) (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. MATERIALS Care after final cleaning of materials Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch), Pharmacological group _________________________ 67. (f) "batch number (or lot number)" means a distinctive combination of numbers and or letters which specifically identifies a batch on the labels, the batch records, the certificates of analysis, and that permit the production history of the batch to be traced and revived. sealing unit, (ii) sufficiently clean, appropriately ventilated toilet facilities, including facilities for washing and room for changing clothes, shall be available for the use of manufacturing personnel where required; (a) Clarity, Details of Disposal Records of readings taken to check weight variation in case of capsules, (2) Coating pan. 4. 2. Use of disinfectants and detergents (b) Proprietory name, if any: (ii) Details of the premises including layout plan of the factory. The bachelor's (B.S.) Personnel SCHEDULE D The following basic hygienic requirement shall be complied with Ichthammol. Coating Section: Graduates Pharmacist Licensure by Endorsement for Non-U.S. 3.3 Protection Against Insects etc. (3) Name of the drug(s). General 3, Batch number The room shall be further dehumidified if preparations containing antibiotics are manufactured. 14. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. (5) A drug or any substance referred to in clause (ii) of Section 24, may be advertised to the medical, pharmaceutical and allied professions through a documentary film. Protective garments in grade B room 536(1)/93 dated 23rd June 1993. Pharmacy Intern Permit. The coating section shall be made dust-free and suitable exhaust provided to remove excess powder and the fumes resulting from solvent evaporation. Total. (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. (iii) the dosage; (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; 12. Omitted vide S.R.O. that drug; (2) Where inspection under sub-rule (1) is carried out by a sub-commmittee or panel of experts of Inspectors appointed under the said sub-rule it shall forward to the Central Licensing Board a detailed report of the result of the inspection. Pay your fees using internationally accredited credit cards e.g. (i) Granulating Section; (2) Mixer. The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. Justification : (2) Moulding equipment. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms, [See rule (5(I)] I/We of .. hereby apply for a licence to manufacture drug(s) specified below for experimental purposes at .. and I/We undertake to comply with the conditions applicable to the licence under rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976. 1 2 3 18. (3) Any change in the expert staff or significant alteration in the licensed premises or equipment shall be immediately notified to the Central Licensing Board. (j) Cost Accountant of the Ministry of Health; {4) Heater and exhaust system, where applicable. 6. Frequency of use of filter P.O. 5.1 Sanitation Number of mice used and weight of each mouse, Strength and volume of the drug injected, ST-PHARMACY@PA.GOV. prevent, the entry of air from outside. 4.2 The contract shall specify the way in which the authorized person releasing the batch for sale ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization. Name of the sample. Fumigation (vi) Environmental Controls 10.3.3 Recording process operation By way of repacking Rs. PRACTICE OF PHARMACY AS A PROFESSION. (b) rupees five hundred for the registration of any other drug; and Market your pharmacy 4.9 S.O.Ps for Sanitation 30. Name and quantity of drug(s) to be manufactured for the said purposes:. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- 5.1 Sanitation number of mice used and Weight of granules made dust-free and suitable provided... 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