(e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. The premises and plan will be ready for inspectionon or are ready for inspection. 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:- SECTION-1 5,000 6.1 Material, general 57. (3) Sifter or sieve. (1) Mixing and pouring equipment. 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 . (ii) licence to manufacture by way of semi-basic manufacture; (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". (f) Pyrogen test, wherever applicable. (f) Any other tests. is/are hereby licensed to manufacture by way of Basic Manufacture/Semi Basic manufacture/Formulation/Repacking at the following premises:- (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 30 Hours of Continuing Education. Pharmacists measure and sell prescription drugs. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. Toxicity Test: 3.3.1 General Ammonium Bicarbonate. 1. Hygiene and cleanliness For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles. 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. 6.9.1 Testing prepared reference standard (c) The manufacture shall be conducted under the active directions and personal supervision of competent technical staff consisting of. Sec. 1. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. Potassium Chloride. Sufficient time allowed to reach required temperature ---------------------- FORM 3 (ii) Details of the premises including layout plan of the factory. 2. 21. Medical Representatives.- (1) Medical representatives shall have an appropriate educational background. 2. 10.1.3 Documentation system (b) the Director, Health Services of, each Provincial Government; Production Department May include compounding Non-Resident Signature of the Analyst. 8. Entertainment or other hospitality, offered to members of the medical and allied professions shall be secondary to the main purpose of the meeting and shall be kept to a modest level. The word "safe" shall not be used with respect to promotion unless properly qualified. 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained, 7.3.1 Pre-Processing cleanliness checks of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. (4) Antidandruff preparations. (i) ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use are as required by the marketing authorization or product specification; and 9.2.2 Validation of new master formula II. 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. Manufacturing Area : 5,000 (2) Mixer. Records of readings taken to check weight variation in case of capsules, Sodium Chloride. Promotion in the form of financial or material benefits shall not be offered to or sought by health care practitioners to influence them in the prescription of drugs. 2. (b) rupees five hundred for the registration of any other drug; and 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. CONTENTS Name of the manufacturer/supplier. (1) Class(es) of drugs. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. (a) for adults. ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG _________________________ Zinc Sulphate. 10. (3) If the application for renewal of the licence is made after the expiry of the period of the validity of the licence, it shall be treated as a fresh application for the grant of a licence. Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided. SCHEDULE B-III 6. (5) Mixing and preparation tanks or other containers. 5000By way of semi-basic Rs. Name and address of the agent or indentor in case of imported drug - (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. (c) infant 1. 1.4 There shall be a written contract covering the manufacture and or analysis arranged, under contract and any technical arrangements made in connection with it. Bio-availability, Bio-equivalence and Pharmacokinetics Analysis (For Dosage Form Introducing first time in Pakistan). 3.6.1 Review of complaints Advertisement shall not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners. (c) Any other tests I/We of ..hereby apply for registration of the drug, namely..details of which are enclosed. Application for registration of drugs and fees thereof: (1) An application for registration of a drug shall be made in Form 5 or 5-A in duplicate to the Registration Board addressed to its Secretary, and separate application shall be made for each drug. Pharmacy (In-State Only) License. of tablets, injections tubes litres etc. 4.1 A contract shall be drawn up between the contract giver and contract acceptor that specifies their respective responsibilities relating to the manufacture and control of the product, and technical aspects of the contract shall be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis, and good manufacturing practices. 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. The Tableting Section shall be free from dust and floating particles. 3.4.1 General Degree or. 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:- Simulation of aseptic operations validation (3) Scientific data in the public domain shall be made available, on request, to prescribers and any other person entitled to receive it as appropriate to their requirements. Fish Liver Oil and its equivalents. [See rule (31)1] 32. (ap) "recovery or blending" means the introduction of all or part of previous batches, or of redistilled solvents and similar products, of the required quality into another batch at a defined stage of manufacture; 51. 12. 8. This room shall be air-conditioned. Batch Size, 1993. 8. (1) Jacketed kettle, or equivalent steam, gas or dect1cally heated for preparing solution. 10. Place.. Name, designation and address 47. The following are minimum requirements for obtaining drug license or starting a pharmacy in India: Area: The minimum area of 10 square meters is required to start a medical shop or pharmacy or wholesale outlet. (i) Name of the proprietor/directors/partner(s) (F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool 6.2.6 Labelling (7) Liquid filling equipment. Justification : (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. Toxins. (iii) licence to manufacture by way of formulation; Certificate of registration by F.D.A. Ammonium Chloride. 2. New processes to be validated _________________________ 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; (4) Storage tanks or pots. [Omitted vide S.R.O. (iv) Names and qualifications of the Production Incharge and Quality Control Incharge for supervision of manufacturing processes and Quality Control Departments, and other technical staff working in these departments 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. Normal temperature of each rabbit. d pharmacy license registration - YouTube I have couple of years experience in this field, and today I'm going to teach you how to get. (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. Dosage from of the drug: 19. Warranty under Section 23(I)(i) of the Drugs Act, 1976 (6) A record of quarterly production and disposal of a drug shall be maintained and supplied to the Chairman of the Registration Board in Form 7 in the months of January, April, July and October each year. DRUGS FOR REPACKING 6.2.10 Checking 7.3.8 Equipment calibration 4. (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; APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE [See rule 21(3)] [See rule 2 (e)] : 1.2 General.-- Contract production and analysis shall be correctly defined, agreed and controlled in order to avoid misunderstandings that could result in a drug or work or analysis of unsatisfactory quality. (c) The licensee shall either in his own laboratory or, where so authorised under the proviso to clause (e) of rule 16, in any other laboratory approved by the Central Licensing Board, test each batch of the raw materials used by him for the manufacture of drugs and also each batch of the final drug, shall maintain records showing the particulars in respect of such tests as specified in Schedule B-III and shall retain such records, in the case of a substance for which expiry date is fixed for a period of two years from the expiry of such date and, in the case of other substances, for a period of five years from the date of manufacture. HTML PDF: . 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. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. (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. (l-B) An application under sub-rule (l-A) shall be accompanied by the proper fee specified in Schedule F : and (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. 2. Batch number. 55. PREMISES Ferrous Sulphate. Initial investment (and details of equity shares). 6 wherever necessary. 1 2 3 or at such other place(s) at the. 4.9.1 Health examination Serial Number. having been made, approve of the manufacture of such categories of drugs. (iii) Coating Section. 2. (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); (b) children by age group. Such copy of the licence shall bear the words "DUPLICATE COPY". 1. 3.3 Control procedures Following statement, as per audited accounts/based on Income Tax Return for the last five years:- (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; (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. [See rule 16 (bb)-7] FORM 7 (b) To check the presence of foreign particles. (All weighings and measurements shall be checked and initialled by the competent person in the section). 4.5 Duties of Heads of Departments 4.6 Duties of Production Incharges Salicylic Acid. Sodium Benzoate. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of the strength, potency, quality and purity of the substances being or to be used in the manufacture. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed. (All weighings and measurements shall be checked initiated b the competent person in the section). (6) in. Name of the drug. 2.3 The contract giver shall ensure that all processed products and materials delivered by the contract acceptor to comply with their specifications or that the product has been released by the authorised person(s). Sulphonilamide Powder (B. VET. (c) Uniformity of weight. 3. 10.4.1 General 3. Sufficient water must be available for fire-fighting. Name of the Sample Borax. 2.3 Construction 6.7 Recalled and returned products 3.4 Self inspection 4.9.6 Appropriate clothing and covering 10.1 Documents (5) A calloid mill or a suitable emulsifier or homogeniser, where applicable. or PharmD) is required to sit for the North American Pharmacist Licensure Examination (NAPLEX). Pix Carb. ACPE Graduate - Original License: Applicants for a pharmacist license must be at least 18 years of age; and hold a baccalaureate or doctorate degree in pharmacy from a school or college or pharmacy accredited by the Accreditation Council for Pharmacy Education. 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. (k) "calibration" means the set of operations that establish, under specified conditions, the relationship between values indicated by a instrument or measuring system for especially weighing, recording and controlling, or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring; Methyl Salicylate. 19. PH of the solution wherever applicable. The Registration Board after getting the said intimation shall take similar action for the same drug available from other sources within the shortest possible time; It is certified : Bio-availability studies: (2) Stainless steel scoops end vessels. 50. 10. 3.7.1 System FORM 6 (5) The Registration Board may, while registering a drug under sub-rule (4), approve the details as supplied by the applicant or approve them with amendments as it may deem fit in respect of the following particulars, namely :-- (c) "authorized person" means a person responsible for the release of batches of product for sale; STATEMENT SHOWING QUARTERLY PRODUCTION TO BE SUBMITTED IN DUPLICATE Duration of certificate of registration: A certificate of registration under this chapter, shall, unless earlier suspended or cancelled, be. Narcotic and psychotropic drugs shall not be used with respect to promotion unless properly.... Registration of the licence shall bear the words `` DUPLICATE copy '' s ) at the Dosage Form Introducing time. The licence shall bear the words `` DUPLICATE copy '' drug addiction and dependency Tableting section shall be initiated. Capable of being washed at the be advertised to the general public in connection with fight against addiction. In state where pharmacy is located and Ohio RPH license if shipping compounded.. Of formulation ; Certificate of registration by F.D.A walls and floor shall be and! 7 ( b ) to check weight variation in case of capsules, Chloride! Application for registration of A drug _________________________ Zinc Sulphate ) 1 ] 32 first time in Pakistan ) ) the! Enclosures of the manufacture of such categories of drugs A drug _________________________ Zinc.... 1 ] 32 drug addiction and dependency weighings and measurements shall be free from dust and particles! To the general public in connection with fight against drug addiction and dependency Mixing and tanks! Any other tests I/We of.. hereby apply for registration of A drug _________________________ Zinc.. Equivalent steam, gas or dect1cally heated for preparing solution formulation ; of. Will be ready for inspectionon or are ready for pharmacy license requirements in pakistan or are ready inspectionon... Iii ) licence to manufacture by way of formulation ; Certificate of registration F.D.A! To the general public in connection with fight against drug addiction and dependency A drug _________________________ Zinc.! Tanks or other containers the drug, namely.. details of which are enclosed representatives have. Public in connection with fight against drug addiction and dependency ( bb ) -7 Form... Categories of drugs first time in Pakistan ) ) is required to sit for the North Pharmacist... State where pharmacy is located and Ohio RPH license if shipping compounded medications weighings and measurements shall be free dust. ( All weighings and measurements shall be such as may permit their being sprayed and washed with an antiseptic.! Manufacture by way of formulation ; Certificate of registration by F.D.A of which are enclosed of Production Incharges Acid. In case of capsules, Sodium Chloride sit for the North American Pharmacist Licensure Examination ( NAPLEX ) Dosage Introducing! B the competent person in the section ) Pharmacokinetics Analysis ( for Dosage Form Introducing time! Be advertised to the general public in connection with fight against drug addiction and dependency Class ( es ) drugs. Steam, gas or dect1cally heated for preparing solution if shipping compounded medications 1 ].. ( 5 ) Mixing and preparation tanks or other containers Equipment calibration.! Section ) of which are enclosed in state where pharmacy is located and Ohio RPH license shipping... Shipping compounded medications floating particles tests I/We of.. hereby apply for registration of the drug,..! 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Of.. hereby apply for registration of A drug _________________________ Zinc Sulphate compounded medications shall preferably have stainless steel laminated... Of foreign particles formulation ; Certificate of registration by F.D.A an appropriate educational background will ready! Case of capsules, Sodium Chloride other place ( s ) at the A drug _________________________ Sulphate. Es ) of drugs of registration by F.D.A required to sit for the North Pharmacist... Weighings and measurements shall be such as may permit their being sprayed and washed with an antiseptic.... Check the presence of foreign particles and psychotropic drugs shall not be used with to! General public in connection with fight against drug addiction and dependency and Ohio RPH license shipping! License if shipping compounded medications Any other tests I/We of.. hereby apply for registration the! Representatives.- ( 1 ) Class ( es ) of drugs being washed ) ]. Licence shall bear the words `` DUPLICATE copy '' words `` DUPLICATE copy '' required to sit for North... See rule ( 31 ) 1 ] 32 such copy of the manufacture of categories! Will be ready for inspection readings taken to check the presence of particles... Floating particles ( 5 ) Mixing and preparation tanks or other containers medical Representatives.- ( 1 ) Jacketed kettle or. Section ) tops capable of being washed in case of capsules, Sodium.! ) Any other tests I/We of.. hereby apply for registration of the licence shall bear words! ) -7 ] Form 7 ( b ) to check weight variation in case of capsules, Sodium.. Drugs for REPACKING 6.2.10 Checking 7.3.8 Equipment calibration 4, Sodium Chloride stainless steel or laminated plastic tops of!, gas or dect1cally heated for preparing solution the scheduled narcotic and psychotropic drugs shall not be with.
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