prevent, the entry of air from outside. (C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. The application fee is $147. 8. (a) The generic name(s) of the active ingredient(s); Programme participants are normally referred to as 'pharmacy interns'. Proposed dosage: 6. Actual production and packing particulars. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. Form 1 4.2 Design 6. (c) as soon as possible and in any event within fifteen working days of their receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (g), (h) and (i) of sub-rule (8). (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - 3.3.3 Test requirement for starting and packaging materials 2.1 General Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. 9. You will need to pay a fee of 687, which covers the cost of processing your application. (i) Layout Examination Procedure: 1. (a) recommended clinical use and the claim to be made for the drug. 5. 36. Name of drug. Provided further that a person already approved by the Central Licensing Board as the production incharge of a pharmaceutical firm shall continue to be the technical supervisor of that firm for the purposes of this rule. Graduates Pharmacist Licensure by Endorsement for Non-U.S. (B) For the renewal of Registration Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; While introducing the drug to the physician for the first time in shall contain full product information, on the basis of the approved scientific data sheet or similar document and shall contain, among others, the following information:- (r) "Form" means a form set forth in Schedule A; 4.4 Quarantine APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. 7.4.4 Process continuity (6) Hot air drying ovens. Name of all ingredients, quantities required for the batch size, quantities actually used. Substances required to be prescribed under Section 24: Any substance or a mixture of substances offered for sale which is injurious, or likely to become hazardous, to the health of a person shall be deemed to be a substance for the purpose of Section 24 of the Ordinance. Measurement of radiation 4. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. 20. SECTION--5 In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. (b) Identification. Contract Giver 12. (b) Preparation of solution: This includes preparation and filteration of solution. RECORDS OF RAW MATERIALS 7.4.6 Label verification A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. (b) the content of active ingredient(s) per dosage form or regimen; MANUFACTURE BY WAY OF FORMULATION Types of licences to manufacture drugs: Licences to manufacture drugs shall be of the following types, namely :-- (8) Hot Air Steriliser, 3. FORM 4 In order to apply for a license or submit a service request, you must first have a DELPROS user account. (a) The generic name(s) of the active ingredient(s); Certificate of registration: A certificate of registration of drug shall be issued in Form 6. CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION Name of the sample. General 13. Signature of the Analyst. The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule. Zinc Oxide. 1. 10.1.5 Product labelling (1-C) The approval of the advertisement, granted under sub-rule (1), shall be valid for a period of two years only. Contract acceptor Schedule an inspection 10. Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG 9. Caffein and its Salts. Name and address of the manufacturer Validation (j) One Surgeon, to be nominated by the Federal Government. 2. Validation Protective garments in grade B room Rs. in the country of origin (in English and in Form 5 (c) : (A) For the grant of Registration Rs. 7. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case. CONTENTS pharmacist registration renewal process in india. III. [See rule 26 (3)] S.R.O. (ii) licence to manufacture by way of semi-basic manufacture; 2. Note: Particulars regarding various tests applied (including reading and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. 30 Hours of Continuing Education. (ii) a degree in science with chemistry or pharmaceutical chemistry as the principal subject who, for the time being is working as incharge of a licensed pharmaceutical manufacturing unit, has not less than ten years practical experience in the manufacture of drugs intended to be manufactured knowledge of pharmacy which, in the opinion of the Central Licensing Board is adequate for the purposes; or 27. 6.6.1 Storage and disposal 50. (c) infant 6.10.1 Storage (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; 19. Bioburden to be minimal 1. 16, Records on the disposal of rejected batches and batches with-drawn from the market. Simulation of aseptic operations validation (c) adequate arrangements shall be provided for carrying out the tests for strength potency, quality and purity of the drugs to be repacked. (13-A) The licensee or his authorised agent shall issue a warranty in Form 2-A For any drug sold by him for the purpose of re-sale or distribution. (vii) Packaging Benzoic Acid. 4. and Denmark. By way of formulation Rs. 10. 6.5.1 Quarantine PROFORMA (iii) Written Procedures 5. (c) Recommended storage conditions and expiration date to be assigned to the specific formulation and package.. Sodium Carbonate. in Pharmacy. 1. This license is not granted until before inspecting the premises and consequently issuing of inspection report after which the licensing authority shall issue a license for Pharmacy or Medical Store. 10.1.3 Documentation system Name of the sample. 3. (5) The meetings of the Central Licensing Board may be held at such time as the Board may deem fit and, on the request of any of its members, the Chairman may at any time call a meeting if there is any important matter for its consideration. (2) All claims concerning a drug for the purposes of promotion shall be reliable, accurate, truthful; informative, balanced, up to date, capable of substantiation and in good taste. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; Super Easy Way to Start Pharmacy Business in Pakistan! 1. (g) The applicant shall provide-- (ii) the route of administration; Disciplinary and criminal history for owners and officers of the pharmacy. 6.2.2 Purchase from producer or established supplier [See rule 20 (b)] (1-A) An application for advertisement of any drug, substance, remedy, treatment or offer of treatment for any disease shall be made it Form-8, addressed to the Secretary of the Commissioner on Advertising and there shall be made a separate application for each advertisement. (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals 11. Fumigation 6. (b) PH wherever applicable, (ii) Testing Procedures 6.2 Changing Rooms 10. 19. Sexual importance. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. (b) The applicant shall provide adequate space, plant and equipment for the manufacturing operations, the minimum space, plant and equipment for various operations are specified in Schedule B-1. 42. 2. [See rule 16 (6) (b)] State Board of Pharmacy. Use the following forms and instructions to complete the application process: License Examination Instructions. 6.4 Intermediate and bulk products No. Year Investment Turn-over 3.3 Areas PART-II In case of a new drug (entity) not yet registered in Pakistan : or an officer of the Provincial Health Department not below the status of Additional Secretary, to be nominated by the Secretary, Health Department of that Province. (a) Generic/international non-proprietary name: 4.8 Packaging Materials (1) Mixer. of pharmacy degree is no longer offered in the U.S. Pharmacy Admissions 17. 6.2.11 Labelling 8. SECTION--2 How to get a pharmacy license in Pakistan? We recommend that you send all supporting documentation to NABP at the time of submitting your application. 8. (5) Pessary and tablet counter. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- Monitoring each cycle 6.2.4 Damaged container 4.6 Rejected Materials Temperature of each rabbit noted at suitable intervals, Processing (ab) "master formula" means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls; By way of repacking Rs. Summed response, 4. Date Signed. Name and quantity of drug(s) to be manufactured for the said purposes:. EQUIPMENT FOR PRODUCTION Note:-Strike off which is not applicable (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- PRACTICE OF PHARMACY AS A PROFESSION. (ii) If the application for renewal is made after the expiry of the period of validity of licence but within sixty days after expiry of the period validity: Results and remarks, Information for patients contained in package inserts, leaflets and booklets.- (1) Adequate information on the use of drugs shall be made available to the patients where it is necessary for rational use of a drug. 4.4 Manufacturing, analytical and distribution records and reference samples shall be kept by, or be available to, the contract giver, and any records relevant to assessing the quality of a product in the event of complaints or a suspected defect shall be accessible and specified in the defect or recall procedures of the contract giver. Location and Surroundings . (Seal) Chairman, Central Licensing Board. 1. Explanation: The expenditure on pay and allowances of the field force connected with the promotional activities shall not be included in expenditure for the purpose of this rule. (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; 26. 3.6.6 Follow-up action Serious illness liable to endanger the life of the patient (e.g., pneumonai, pleurisy, abscess of the lungs). Pharmacy Services Health Department KP. 4.1 General [Omitted vide S.R.O. (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. Protocols of tests applied: 4. This registration is subject to the conditions specified in the Drugs Ordinance/Act, 1976, and .the rules thereunder and to the conditions specified in the enclosure. (6) Antacid and carminatives: (4) Filling equipment. 57. (iii) Specifications By way of repacking Rs. Clothing requirements Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- 25. (4) Oven thermostatically controlled. 2.2 Terminally sterilized products PART-I (d) special groups. 4. Household remedies including-- In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :-- Using double filter layer [See rules 28 and 29(4)] (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; Ferric Ammonium Citrate. (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; Sodium Citrate. This licence shall unless previously suspended or cancelled be in force for a period of two years from the date specified below:- Name of the Firm. 10. 4. Symposia and other scientific meetings.- The intimation regarding scientific symposia, seminars, conferences and such meetings where sponsored by a pharmaceutical manufacturer or distributor shall be clearly communicated in advance. (5) Mixing and storage tanks of stainless steel or of other suitable material. (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. Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly. 3.3.7 Stability studies Suitability of process Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. {4) Heater and exhaust system, where applicable. (2) Where a person possesses or applies for a licence to manufacture by way of formulation and he also intends to conduct repacking of drugs, he may conduct such repacking under the same licence subject to the approval of, and under such conditions as, the Central Licensing Board may specify. wherever necessary The training shall include instructions regarding appropriate ethical conduct taking into consideration the W.H.O. Date of commencement of manufacture and date of completion. Bismuth Carbonate. (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. (ii) Others Pharmacy (In-State Only) License. *Number of Registration and date of issue if plicable. The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. SECTION--4 (3) The members of the Central licensing Board, other than its ex officio members, shall hold office for three years and shall be eligible for renomination. Date and methods of filtration. (i) enclose certificate of registration and Free Sale from any of the following countries: (7) Autoclave, 113-54 (Drug Supply Chain Security Act). 8. Date of release of finished packings for distribution or sale, 1993. Practiced pharmaceutical profession for a period not less than two years (for foreigners) Fluent Arabic and foreign language. Licensing requirements for Michigan healthcare and pharmaceutical companies and individuals. Application Module: For pharmacies, drug store owners, and proprietors to apply for a license. Registration Board: (1) The Registration Board shall consist of such members, including the I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at Proposed dosage : 5. (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. 38. 31. (4) Every drug shall be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. (3) Sealing equipment, Personnel 6.9 Reference standards Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. or the director or manager of the firm or company by which, the drug will be manufactured. By way of basic Rs. This room shall be air-conditioned. 21. Please contact the Board at pharmacy@ks.gov for more information. (i) licence to manufacture by way of basic manufacture. Use of vacuum
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