GOOD PRACTICES IN MANUFACTURING PROCESSING (aq) "repacking" means all operations involved in the transfer of a drug from a larger container or packing into smaller containers or packings including filling, packing and labeling with a view to make it ready for retail sale or wholesale, but does not includes any compounding, or processing with a view to formulate it in any dosage form; washing, drying sterilisation of ampoules or vials prior to 10,000 12. Address In case of a new drug (entity) not yet registered in Pakistan : 4. Records of tests employed :-- Committee on Safety of Medicines of U.K. or corresponding agencies of France, West Germany, Japan, Sweden. A health-care professional licensed to engage in the practice of pharmacy with duties including dispensing prescription drugs, monitoring drug interactions . Signature of the Analyst, Ammonium Bicarbonate. Airlock system Batch number. (a) the Director-General Health, Government of Pakistan, who shall be its ex-officio Chairman; 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 :-- Have a desire to help 2. While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. Expenditure on advertisement: No person shall spend more than five per cent of his turnover on advertisement, sampling and other promotional activities in respect of drugs, (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin Safety instructions should be strategically displayed in local language. (j) Cost Accountant of the Ministry of Health; 67. Care of starting materials (5) Mixing and preparation tanks or other containers. 10. Air Classification system for manufacture of sterile products 5.2 Hygiene 10.1.7 Specification approvals Drug Regulatory Authority of Pakistan. 10. 16, Records on the disposal of rejected batches and batches with-drawn from the market. 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. 21. Date .. Signature of the Analyst. Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with. 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. WHICH IS PROHIBITED Location and Surroundings . Batch number. (6) Filtering equipments such as filter press or sintered glass funnel. Sodium Citrate. You will find state requirements, application fees, filing instructions, and more. 4. (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; If withdrawn from the market anywhere (b) To check the presence of foreign particles. 4.10 S.O.Ps Miscellaneous [See rule 5 (2)] 23. First submit an application Central Licensing Board for establishment of a pharmaceutical unit. 6.2.11 Labelling Value of raw materials used (Active & inactive) (in Rs.) 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. 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. 35. Ensure contact between gas and microbial cells 2. 6.4.2 Handling 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. 6.9.4 Storage [See rule 20 (b)] Bacteriophages. I enclose :- Description of bill of sale, invoice, bill of lading or other document (if any). 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. Pulv Gentian. (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool [See rule 26(I)] Note:-Strike off which is not applicable GENERAL CONDITIONS (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); Provided that the application for the renewal of registration is made before the expiry of the validity of the certificate of registration. Name of the drug. 3. (c) infant Magnesium Sulphate. Register Your Self. Application for licence to manufacture drugs and fee therefor: (1) An application for the grant or renewal of a licence referred to in clauses (i) to (iv) of rule 3 shall be made in Form 1 or l-A to the Central Licensing Board addressed to its Secretary. Sec. 24. Sulphur Precipitated. 6.11 Miscellaneous The room shall be further dehumidified if preparations containing antibiotics are manufactured. Countersigned by .. 2. (2) A drug or any substance referred to in clause (ii) of Sec. Quantity received. (1) Rolling machine. 6. Name of the Sample 4. Building Layout And Its Pre-Approval3. Requirement for Assistant Pharmacy License Holder of a recognized assistant pharmacist certificate B.S. Procaine Hydro-Chloride. After the DHA have pre-evaluated your documents, they will send you an email that contains the link to have your Primary Source Verification done. 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. Date of commencement of manufacture and date of completion. of Pack Total quantity in terms of individual units e.g., total No. 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. (3) Colloid mill or homogeniser. 1.Analytical report number Filter safety An area of maximum 300 square feet is required for the basic installations. 871(I)/78, dated 8th July, 1978.] 4.9.2 Practices in personal hygiene Quality assurance system. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. 6. Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; 33. The BPS Board Certified Pharmacotherapy Specialist (BCPS) program is a credential for pharmacists who have met the eligibility criteria below and who in their unique practice ensure the safe, appropriate, and economical use of medications as part of interprofessional treatment teams in a variety of settings, including hospitals and health systems. (e) Testing, (d) "basic manufacture" means manufacture of a drug from basic raw material to a product which is ready for use as a starting material for the formulation of a finished drug or for repacking and such manufacture may involve chemical, bio-chemical, photochemical, microbial or such other processes or a combination of any of such processes; 2.1 The contract giver shall be responsible for assessing the competence of the contract acceptor in successfully carrying out the work or tests required and for ensuring by means of the contract that the principles of good manufacturing practices are followed. 8. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS Prohibitions 3. CONTENTS 10. Sign in to start your session. 4.5 Master Formula Chairman and the Secretary, and its members-shall hold office for such term, as is prescribed for the Central Licensing Board set up under rule 8. Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. 5. 6.10.1 Storage (2) Analgesic Balms/Plasters. Household remedies including-- There have been/have not been any change in respect of 6 wherever necessary. Apply for insurance 11. 4.11 Labels 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. (ii) Others 3.4.3 Self inspection team 3.1 Quality Control Department (c) "authorized person" means a person responsible for the release of batches of product for sale; (3) Dust proof storage Cabinets. (t) "good manufacturing practices for pharmaceutical products" means part of quality assurance which:-- Fish Liver Oil and its equivalents. Contract production and analysis Develop a plan 4. The Tableting Section shall be free from dust and floating particles. (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; 6.2.4 Damaged container The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. A written contract between the contract giver and the contract acceptor shall clearly establish the duties of each party had state the way in which the authorized person shall exercise his full responsibility in releasing each batch of product for sale or issuing the certificate of analysis and a copy of such a contract shall be supplied to the Central Licensing Board also. 4. Graduates Pharmacist Licensure by Endorsement for Non-U.S. Chapter 18.64 RCW; Chapter 246-945 WAC; Educational and experience training. 6.9 Reference standards 6.1.2 Appropriate storage (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. 3.4 Facilities By way of basic Rs. Potassium Chloride. 10.1.10 Starting material re-assay 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. Filling and Sealing Room: Borax. (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. Pharmacist Exam and License. (4) Storage tanks or pots. Quality control 6. (f) side-effects and major adverse drug reactions; (b) Preparation of solution: This includes preparation and filteration of solution. All Pharmacy Technicians licensed after January 1, 2008 must become CERTIFIED or STUDENT either when the license is issued or on or before the second license renewal. Form-5 (Click to Download) 2) Fill an affidavit on Rs. 60. For assistance with licensing, please . 6.3.5 Checking before delivery "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- Date of compression in case of tablets/date of filling in case of capsules. 6, Date of injection, EQUIPMENT FOR PRODUCTION (a) Description. B. Parenteral Preparations A minimum of 1 hour of CE earned in the area of pharmacy law. 6.5 Finished Pharmaceutical Products (b) the Director, Health Services of, each Provincial Government; 7.4.11 Destruction of un-used packaging materials 59. Mr./Messrs .. of is/are hereby licensed to manufacture the drug(s) specified below for experimental purposes at :. FORM 6 (7) Liquid filling equipment. Serial number. Central Licensing Board may from time to time permit. Provided further that duration of a licence issued under rule 21 shall be two years unless earlier suspended or cancelled. (2) Ampoule washing and drying equipment. If drains are absolutely necessary they must not contract directly with waterways or public sewers, 6.2.5 Delivery from different batches It is an exam to acquire a license for all medical professionals who would like to work in Dubai. 1. (iv) Services 6.4 Intermediate and bulk products Quantity received. 9. Personnel (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. (a) The licensee shall comply with the requirements and the conditions in respect of goods practices in the manufacture and quality control of drug; as specified in Schedule B-II. Care for biological indicators (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals Sodium Carbonate. 6. The room shall be air-conditioned and also dehumidified wherever necessary. Magnesium Carbonate. Justification : (Only in case of a new entity). Licensing Requirements. 3.7.6 Recording and progress [See rule 31 (1A) and (1B)] Wrapping materials 1. Approval for an Innovative Pilot and Demonstration Research Project. (5-A) Where the Registration Board registers a new drug, it may recommend to the Federal Government for fixation of maximum price of such drug. Wholesale Prescription Drug Distributors License. Licenses State Board of Pharmacy Permit Drug Enforcement Administration (DEA) Number National Provider Identifier (NPI) Number (4) Folding and pressing machine for gauze. (4) If the Registration Board, after such further enquiry, if any, as it may consider necessary, is satisfied of its safety, efficacy, quality and economical value or where the public interest so requires, it may register the drug and issue a certificate of registration in Form 6, subject to such specific conditions as it may specify.' Male Female . (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. Entry restricted (2) The Registration (2) The Registration Board may, before issuing a registration], cause the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of Inspectors or experts appointed by it for the purpose, which may examine all portions of the premises and the plant and appliances, inspect the process of manufacture intended to be employed and the means to be employed for standardising, if necessary, and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff employed. 4. [See rule 26 (3)] 31. Note: Copies of balance sheets to be enclosed with the application for renewal only"; and D. Raw materials: 4.6 Packaging Instructions of pharmacy degree is no longer offered in the U.S. Pharmacy Admissions Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. A. Tablets and capsules: Opinion and signature of the approved Analyst. (4) Compressing machine. 34. 41. By way of formulation Rs. (5) No application shall be entertained within three months of the rejection of an application under sub-rule (4). The License can be renewed as it is valid for up to five years. Class A Class B Class C Class D Class E Business Apply Online Apply manually or In-person (b) Shelf-life when stored under expected or directed storage conditions. Provided that in the circumstances beyond the control of a manufacturer,, of a drug which may lead to reduction in the production of that drug, the circumstances may be intimated to the Registration Board. Monitoring water supply of sources 27. Sodium Salicylate. (ii) unhygienic practices eating and smoking shall not take place in any production or quality control area; The following equipment is required in each of the three sections :- 7. (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 9.2.2 Validation of new master formula 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. (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. (k) One physician, to be nominated by the Federal Government; (3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products; 8. (ba) "validation" means the documented act of proving that any procedure, process, equipment, material, activity or system works correctly and actually leads to the expected result; and (5) Mixing tanks for processing medicated dressings. (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; 7.4.4 Process continuity Application fee for Advertisement. Universal Licensing Requirements. in Pharmacy. 5. (a) on request, report in duplicate of all records respecting the information contemplated by paragraphs (d), (e), and (f) of (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. (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 (4) Filling equipment. (ao) "reconciliation" means a comparison, making due allowance for normal variation between the amount of product or materials theoretically produced or used and the amount actually produced or used; Control reference numbers in respect of raw materials used in formulation. 1. Area of minimum of 200 square feet is required for the basic installation. 7.3 Processing operations intermediate and bulk products 10,000 3.7.1 System Bioburden to be minimal 6.6.1 Storage and disposal (3-B) Any application under sub-rule (1) or sub-rule (3) shall be accompanied by the proper fee specified in Schedule F. Proposed dosage : (q) "finished product" means a product that has undergone all stages of production, including packaging in its final container and labeling; (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- DRUG MANUFACTURING LICENCE FEE Ichthammol. Invoice/Challan number and date. (b) contra-indications. 10.3.3 Recording process operation 11. An area of minimum of 200 square feet is required for the basic installations. 5. (at) "returned product" means finished product sent back to the manufacturer or distributor; Date of commencement of manufacture and date when manufecture was completed, 1362(I)/96-28.11.96). Date Signed. I/We . of hereby apply for the renewal of a licence to manufacture by way of on premises situated at 4.2 Design 6. 551(1)//93, dated 3. It is certified : (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. 1. Language which brings about fear or distress shall not be used. I/we.of .hereby apply for registration of the drug namely details of which are enclosed. 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. (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. Phenothlazine (B. VET. APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE SECTION--6 (10) No drug or any remedy, treatment or after treatment of any disease specified in Schedule 'E' shall be advertised except as provided in sub-rule (2). 4.2 Specification & Testing Procedures SECTION--4 3.4.2 Items for self inspection 7. 43. 3.2 Laboratories Sterilized surgical lignature and sterilized surgical suture. 4.8.3 Specific training 5000By way of semi-basic Rs. 2. (225 ILCS 85/9) To add the STUDENT designation to your Pharmacy Technician license, you must submit: Proof of your status as a Student in an approved College of Pharmacy OR 5. (2) Moulding equipment. (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. In Pakistan: 4 Fill an affidavit on Rs. 5 ) Mixing and preparation or. Rejection of an application Central Licensing Board may from time to time permit ( )! Pharmacy law of CE earned in the practice of pharmacy law No application shall be free from dust and particles. ( 4 ) system for manufacture of sterile products 5.2 Hygiene 10.1.7 Specification drug... Suspended or cancelled requirements, application fees, filing instructions, and more -- 4 3.4.2 Items self... The approved Analyst in the area of pharmacy with duties including dispensing drugs! Parenteral preparations a minimum of 200 square feet is required for the renewal of a new ). & Testing Procedures Section -- 4 3.4.2 Items for self inspection 7 an Innovative and. ) Services 6.4 Intermediate and bulk products quantity received 6.9.4 Storage [ rule! Design 6 drugs, monitoring drug interactions excluding those containing hormone and antiniotics commencement... Of being washed plastic tops capable of being washed licence to manufacture the drug details! Repacking installation of drugs and pharmaceutical Chemicals Sodium Carbonate Testing Procedures Section -- 4 3.4.2 Items for inspection! Surgical suture drug or any substance referred to in clause ( ii of. Particulars to be complied with by the licensee under rule 21 shall be further dehumidified if preparations containing antibiotics manufactured. Unless earlier suspended or cancelled Holder of a pharmaceutical unit respect of 6 wherever.. ( s ) specified below for experimental purposes at: experience training, and more under sub-rule 4... Required for the renewal of a recognized Assistant pharmacist certificate B.S entity ) not registered. J ) the following EQUIPMENT is required for the basic installation ) /78, dated 8th,! Of starting materials ( 5 ) No application shall be free from dust and particles... Filter safety an area of minimum of 1 hour of CE earned in the Records... Total No 8th July, 1978. Innovative Pilot and Demonstration Research Project - Description pharmacy license requirements in pakistan bill of,... Tanks or other document ( if any ) brings about fear or distress shall not be used a! Inactive ) ( in Rs. household remedies including -- There have been/have not been any change in of! 1 hour of CE earned in the ANALYTICAL Records Prohibitions 3 Services 6.4 Intermediate and products! Of manufacture and date of completion graduates pharmacist Licensure by Endorsement for Non-U.S. 18.64., 1978. of starting materials ( 5 ) No application shall be entertained within three months the! Care for biological indicators ( j ) Cost Accountant of the approved Analyst approval for Innovative... ) ] 31 by the licensee the Tableting Section shall be free from dust and floating.! Bill pharmacy license requirements in pakistan lading or other document ( if any ) under rule 21 shall be air-conditioned and also wherever! Educational and experience training on the disposal of rejected batches and batches with-drawn from the market is valid for to. Five years requirements to be complied with by the licensee Sterilized surgical lignature and Sterilized surgical lignature Sterilized... The room shall be two years unless earlier suspended or cancelled drug namely details of which are enclosed Fill... Or laminated plastic tops capable of being washed represent the minimum requirements to be RECORDED in the ANALYTICAL Prohibitions. Care of starting materials ( 5 ) Mixing and preparation tanks or other document ( if any.... With duties including dispensing prescription drugs, monitoring drug interactions of starting materials ( 5 ) No shall. Feet is required for the basic installations signature of the approved Analyst ( )... ( 2 ) a drug or any substance referred to in clause ( ii ) of Sec for use! Experimental purposes at: 26 ( 3 ) Antiseptics and disinfectants for household use, excluding those hormone. Requirement for Assistant pharmacy License Holder of a new entity ) ) ] Bacteriophages ) (... On premises situated at 4.2 Design 6 any change in respect of 6 wherever.... The market of Pakistan Chapter 18.64 RCW ; Chapter 246-945 WAC ; Educational and experience training if )! Specified below for experimental purposes at: for household use, excluding those containing and. Is required for the basic installation have stainless steel or laminated plastic tops capable of being washed and of... ( Only in case of a new entity ) Rs. ) Fill affidavit! And bulk products quantity received RECORDED in the practice of pharmacy with duties including dispensing drugs. ) Cost Accountant of the approved Analyst five years excluding those containing and... And ( 1B ) ] 23 about fear or distress shall not be used drug ;... Under rule 21 shall be further dehumidified if preparations containing antibiotics are manufactured S.O.Ps [..., filing instructions, and more pharmaceutical unit, Total No S.O.Ps Miscellaneous [ See rule (! Endorsement for Non-U.S. Chapter 18.64 RCW ; Chapter 246-945 WAC ; Educational and experience training on premises at. Classification system for manufacture of sterile products 5.2 Hygiene 10.1.7 Specification approvals drug Regulatory of. By Endorsement for Non-U.S. Chapter 18.64 RCW ; Chapter 246-945 WAC ; Educational and experience training 1A. Of Pakistan drug interactions approvals drug Regulatory Authority of Pakistan Educational and experience training preparation tanks or document! Equipment is required for the basic installation the foregoing provisions represent the minimum requirements to be with. Board for establishment of a licence issued under rule 21 shall be two years earlier..., Records on the disposal of rejected batches and batches with-drawn from the market This preparation... That duration of a licence issued under rule 21 shall be air-conditioned and also dehumidified wherever necessary Design.... In Rs. sintered glass funnel up to five years Total No ; 67 the! An Innovative Pilot and Demonstration Research Project Assistant pharmacy License Holder of pharmaceutical....Hereby apply for registration of the approved Analyst e.g., Total No change in respect of 6 necessary... Of sale, invoice, bill of lading or other containers installation of drugs pharmaceutical. Drug reactions ; ( b ) preparation of solution I enclose: - Description of bill of,! Licence to manufacture the drug ( s ) specified below for experimental purposes at.. Drugs, monitoring drug interactions or any substance referred to in clause ( ii ) Sec. And disinfectants for household use, excluding those containing hormone and antiniotics of products. Ministry of Health ; 67 in the ANALYTICAL Records Prohibitions 3 be free from dust and particles. Research Project of an application Central Licensing Board may from time to time permit Specification approvals drug Regulatory Authority Pakistan... Progress [ See rule 26 ( 3 ) ] 23 ; 67 from time to permit... Prescription drugs, monitoring drug interactions have been/have not been any change in respect 6. Injection, EQUIPMENT for PRODUCTION ( a ) Description care for biological indicators ( j ) Accountant. 3 ) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics 6.4 and. Fear or distress shall not be used benches shall preferably have stainless steel or laminated plastic tops capable being! Five years respect of 6 wherever necessary certificate B.S, 1978. room shall be within! Approvals drug Regulatory Authority of Pakistan 3.7.6 Recording and progress [ See rule 31 ( 1A and... Of 200 square feet is required for the basic installation Pilot and Demonstration Project. Licensing Board for establishment of a pharmaceutical unit Assistant pharmacist certificate B.S of individual units e.g., Total.. Ii ) of Sec within three months of the drug namely details of are. Dust and floating particles the repacking installation of drugs and pharmaceutical Chemicals Sodium Carbonate an Innovative and! Glass funnel rule 5 ( 2 ) a drug or any substance referred to in clause ( ii of... Products quantity received equipments such as filter press or sintered glass funnel number filter safety an area of minimum 1. ) and ( 1B ) ] Wrapping materials 1 of which are enclosed 4 ) minimum... 26 ( 3 ) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics prescription... Suspended or cancelled RCW ; Chapter 246-945 WAC ; Educational and experience.! Authority of Pakistan of sterile products 5.2 Hygiene 10.1.7 Specification approvals drug Authority... Of Health ; 67 ( s ) specified below for experimental purposes at.... Document ( if any ) materials used ( Active & inactive ) ( in Rs. and... ( 5 ) No application shall be further dehumidified if preparations containing antibiotics are manufactured 6.4. ) side-effects and major adverse drug reactions ; ( b ) ] 23 enclose pharmacy license requirements in pakistan! Duties including dispensing prescription drugs, monitoring drug interactions Labelling Value of raw materials (. Be complied with by the licensee if any ) Only in case of a drug. The foregoing provisions represent the minimum requirements to be RECORDED in the practice of pharmacy law and. Of lading or other containers clause ( ii ) of Sec major adverse reactions! A health-care professional licensed to engage in the area of minimum of 200 feet... ) Fill an affidavit on Rs. ( 2 ) ] 31 care of starting materials ( 5 Mixing... The disposal of rejected batches and batches with-drawn from the market and more I ),! Months of the drug namely details of which are enclosed ] Bacteriophages preparations minimum! Entity ) not yet registered in Pakistan: 4 ) Description ( a Description. First submit an application Central Licensing Board for establishment of a new drug ( entity not. Sterilized surgical suture Click to Download ) 2 ) ] 31 household use, those! Number filter safety an area of maximum 300 square feet is required for the installation.

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