Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. Graduates Pharmacist Licensure by Endorsement for Non-U.S. (6) Finished products shall be stored in a suitable separate place. 29. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. 6.9.1 Testing prepared reference standard 15. 7.1.1 General About Us | Contact Us Search You & Your Family Community & Environment Licenses, Permits, & Certificates Data & Statistical Reports Emergencies For Public Health & Health Care Providers In this section Pharmacies QUALITY CONTROL DEPARTMENT (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. (11) The manufacturer or as the case may be, the indentor shall follow the ethical criteria for medical drug promotion as given in Schedule G. 7. (a) "active pharmaceutical ingredient" means a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient); A minimum of 17 hours of CE earned in any combination of the following pharmacy-related subject matter: Medication or drug distribution; Inventory control systems; Mathematics and calculations; Biology; Pharmaceutical sciences; Therapeutic issues; Pharmacy operations; (2) They shall come into force at once. 201 - 208, P.L. Pharmacy (In-State Only) License. (a) recommended clinical use and the claim to be made for the drug. 2. (d) Extreme Temperature Fluctuations Study for all liquid and semi-solid preparations. Finishing of sterile products Potassium Bicarb. 9. (5) Mixing and preparation tanks or other containers. A total area of not less than 900 square feet for the three Sections is required for basic installations. Conditions of licence to manufacture, by way of basic manufacture, semi-basic manufacture formulation and repacking of drugs: (1) A licence to manufacture by way of basic, semi-basic manufacture, formulation or repacking of drugs shall be subject to the conditions stated herein, if any, and to the further condition that the licensee shall continue to maintain conditions on the basis of which he was granted a licence. The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. Name, address and status of the applicant: Provided that the Federal Government may, if in its opinion the public interest so required, withdraw the approval granted to any advertisement or modify or alter any condition subject to which the advertisement was approved. 3.7 Product recalls Gentian Violet. SECTION -- 7 6.7.1 Recalled products Warranty under Section 23(I)(i) of the Drugs Act, 1976 (ii) Where the usual information on indications and dosage is provided, that advertisement material shall contain information on contra-indications, side effects and other necessary precautions as may be applicable. General Perform location analysis 3. SECTION -1 38. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. (j) "bulk product" means any product that has completed all processing stages up to, but not including, final packaging; It is also certified that (a) the manufacturing plant in which the product is produced is subject in inspections at suitable intervals, and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, in respect of products to be sold or distributed within the country of origin or to be exported. 6.6.4 Additional testing of reprocessed materials 10.1.1 Maintenance of documents 10. Sulphur Sublime. [See rule 17(1)] Promotional material shall be factual and claims for cure, prevention or relieve of an ailment shall be made only if this can be substantiated. Name of the Firm. 4. CONDITIONS OF FACTORY PREMISES Sign in to start your session. (b) Shelf-life when stored under expected or directed storage conditions. ], reject the application for registration and inform the applicant of the reasons for such rejection in writing. C.). Form-5 (Click to Download) 2) Follow the instructions provided and fill out an affidavit on papers with a Rs.50.00 stamp ( Click to Download- Affidavit ) 3) Make a deposit in a bank . This licence shall, in addition to the conditions specified in the rules made under the Drugs Ordinance/Act, 1976, be subject to the following conditions namely:- 9.1 General ---------------------- Labeling of drugs manufactured for experimental purposes: (l) Any d-rug manufactured for experimental purposes shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. Sodium Sulphate. 4.8.1 Written programme (b) the Director, Health Services of, each Provincial Government; (A) For the grant of Registration Rs. (3) Colloid mill or homogeniser. 10.4.5 Analytical records 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. (viii) Light 6.3.2 Printed materials Solution of serum proteins intended for injunction. (12) The licensee shall on being informed by the Central Licensing Board or a Provincial Quality Control Board that any part of any batch of a drug has been found not to conform with the requirements of the Ordinance or the rules and on being directed so to do, withdraw the remainder of the batch of such drug from sale and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch and dispose it of in such manner as may be directed by the said Board. 7.2.2 Measures against contamination (8) Autoclave. Patent number, if any, with date and its date of expiry : Have a desire to help 2. 3.4 Facilities 9. (6) Any fee deposited under sub-rule (3)shall in no case be refunded. (3) Cutting equipment. Preparation of live organisms Measurement of radiation D. Raw materials: 3. 6.10.1 Storage 3.6.2 Person authorized (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. (r) "Form" means a form set forth in Schedule A; (b) repacking operation shall be carried out under hygienic conditions and under supervision of technical staff provided for in clause (c) of rule 16; 67. Name of drug, under which it is proposed to be sod: Methylene Blue. (3) Substantiated information on hazards associated with the drug shall be reported to the Registration Board as a priority. Tableting Section: SECTION--3 FIHS is registered with Pharmacy Council of Pakistan and Punjab Pharmacy Council to offer Pharmacy Technician (Category-B) professional diploma. 1. 50. (4) Storage tanks or pots. (D) The following equipment is required for the manufacture of Powders :-- 22. that drug; Type of licence Fee Note: Records racer, cling various tests applied (including reading and calculation) should be maintained and necessary reference to these records should .be entered in serial No. 24. 3.6.5 Investigations SECTION -- 4 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. [See rule 7] GOVERNMENT OF PAKISTAN Following statement, as per audited accounts/based on Income Tax Return for the last five years:- (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. 536(1)/93 dated 23rd June 1993. (g) Toxicity test, wherever applicable. 16. 4.8 Training 56. 7.4.11 Destruction of un-used packaging materials In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. (3} Granular Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. MANUFACTURE BY WAY OF FORMULATION (f) any bacteriological or any significant chemical or physical or other change or deterioration in any batch of that drug; 4.8.3 Specific training and (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F. Universal Licensing Requirements. 6. Specifications with details of analytical procedure (not required in case of a drug for which the pharmacopocial standards recognised under the Drugs Act, 1976 are claimed): 8. Address 2. Gripe Waters. 4. 4.9.6 Appropriate clothing and covering Sodium Carbonate. 35. (i) Cost per retail pack of each active and non-active. SCHEDULE F Proposed dosage : (6) If after the expiry of three months but within six months of the rejection of an application under sub-rule (4), the applicant informs the Central Licensing Board that the requirements of the rules have been fulfilled, the Board may if after causing a further inspection to be made, is satisfied that the conditions for the grant of a licence have been complied with, issue a licence and no further fee shall be required to be deposited for such an application. (c) two pharmacologists, to be nominated by the Federal Government. 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected. 3.7.8 Storage of recalled drugs STEP 4: Apply for PSV. Record maintenance (2) Dosage form(s) of drugs. Signature of the Analyst, One must pass this exam to be registered as pharmacist. (m) "compounding" means scientific combination of two or more ingredients with a view to make a finished drug; 3.7.6 Recording and progress (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. (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. First submit an application Central Licensing Board for establishment of a pharmaceutical unit. 6.4.2 Handling FORM 4 57. (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; DRUG MANUFACTURING LICENCE FEE FORM 3 Each state may have different individual . 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor. (11) Reminder publications for the medical, pharmaceutical and allied professions shall include the name of the drug and its exact composition, the price, the name and address of the manufacturer and a statement to the effect that "Full information is available on request". 10.1.8 Revision of specification (2) If a person is conducting a part of the process of the manufacture on behalf of another manufacturer in accordance with the permission granted under sub-rule (1), and he is not responsible for the quality of the final product, the Central Licensing Board may not require him to establish an independent quality control laboratory for such products. 11. Signature of the expert staff responsible for the manufacture, Degree or. 10.4.4 Recording batch numbers 22. The invitation letter should accurately reflect the presentations and discussions to be held. ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG 15. 7. Sodium Salicylate. 7.4.9 Product re-introduction on packaging line (iii) licence to manufacture by way of formulation; Antigen. Certified that following drug(s) are hereby registered under the Drugs Ordinance/Act, 1976:- [See rule 26(3A)] 190.00 Renewal Fee. 3.2 Services (a) A complete description of and date derived from studies on the stability of new drug, including information pertaining to the suitability of the analytical methods used (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. 17. Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. Date of filling. HTML PDF: 246-945-246: Wholesaler. 6. sealing unit, (b) if a clinical information for a drug is approved by the Drug Regulatory Authority in any of the said countries, the same clinical information shall be considered as approved for drug registration in Pakistan unless modified by the Registration Board on the basis of scientific data available to it, and such clinical information may include indication, contra-indications, side effects, precautions, dosage, etc; 1. Powers of the Central Licensing Board: (1) The members of the Central Licensing Board shall exercise all the powers of an Inspector without restriction as to area, and shall have the powers of a Provincial Inspector in relation to Section 30. Description of the method of manufacture and quality control with details of the equipment. Proposed route of administration. (1) Mixer. 14. Graduates Pharmacist Collaborative Practice Certification (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool 7.4.7 Resistant printing on labels Outside contractor Area of minimum of 200 square feet is required for the basic installation. Bismuth Subnitrate. 1. Proposed C and F and maximum retail price (in case of imported drug) : (5) Mixing tanks for processing medicated dressings. Prescribers and dispenses shall not solicit such inducements. (i) The licence will be in force for a period of five years from the date of issue unless earlier suspended or cancelled. 7. Place.. Name, designation and address 2.2 Layout Method of manufacture and quality control with details of the contract acceptor registration a! And floor shall be stored in a suitable separate place documents 10 certificate from a recognized high,. Live organisms Measurement of radiation D. 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