Contract Giver 7.1.6 Labelling Total. 4.2 Design 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. 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. Provided that: and detailed records must be kept. (ii) Reasons thereof. 17. Monitoring endotoxin GENERAL CONDITIONS (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; (10) Filling and sealing unit (14) The Licensee shall , by the 30th June and the 31st December each year, Whichever is immediately after the annual financial closing of the company. Equilibrium with humidity and temperature 15. 32. Name and address of the manufacturer 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. Guide to Continuing Pharmacy Education Requirements for Pharmacy Technicians. (5) Mixing tanks for processing medicated dressings. Initial investment (and details of equity shares). 6.2 Starting materials 3. 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. (c) infants. Processing 3.3.2 Sampling 6. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained. (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; (iii) Specifications 22. Process to apply for a Drug sales License: 1) Fill a prescribed form-5 in Drug Rules. (au) "Schedule" means Schedule to these rules; 41. (o) "critical process" means a process that may cause variation in the quality of the pharmaceutical product; (ii) Cost of each packing material. (7) Liquid filling equipment. The Doctor of Pharmacy (Pharm.D.) 12. (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. Name of all ingredients, quantities required for the batch size, quantities actually used. An area of maximum 300 square feet is required for the basic installations. 7. 4. DETAILS OF THE FIRM (c) major precautions, contra-indications and warnings, if any; and 7.3.8 Equipment calibration (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. (1) Rolling machine. (9) The following information shall be supplied to the Registration Board-- 20. 13. Potassium Bicarb. GOOD PRACTICES IN MANUFACTURING PROCESSING To LOG IN or CREATE a DELPROS (Delaware Professional Regulation Online Services) user account: Go to: https://delpros.delaware.gov/OH_HomePage. (h) "batch records" means all documents associated with the manufacture of a batch of bulk product or finished product showing a history of each batch of product and of all circumstances pertinent to the quality of the final product; 3.4.5 Self inspection report (9) Miscellaneous. 5. (3) Punch and dyes storages cabinet. 6.2.4 Damaged container 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. 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. (6) A triple-roller mill or an ointment mill, where applicable. 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. Sterility test as the last measures Requirements for a pharmacy permit vary by state, but many permit applications ask for: The type of pharmacy (Retail, Hospital, Sterile Compounding, Nuclear, etc.) (5) The Chairman and the Secretary of the Registration Board shall, after the Board has approved the registration of a drug, sign the certificate of registration. (v) Storage (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. Date of Registration Secretary Registration Board (Seal) Chairman. 4.11 Labels 1. 6.2 Changing Rooms 2. (g) any failure of one or more distributed batches of that drug to meet the required specifications; 4.8.4 Understanding concepts (2) Ampoule washing and drying equipment. Degree or. (5) Dental preparations. SECTION--2 (f) Pyrogen test, wherever applicable. (3) Cutting equipment. 2.4 Piping SECTION -- 4 17. Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). APPLICATION FORM FOR RENEWAL OF A LICENCE TO MANUFACTURE DURGS BY WAY OF FORMULATION/BASIC MANUFACTURE/SEMI-BA SIC MANUFACTURE/REPACKING (3) A suitable power driven mixer. 3.6.3 Written procedures . 3. 5000By way of semi-basic Rs. Comparison of products shall be factual, fair and capable of substantiation. 1. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. 10.1.10 Starting material re-assay (3) The indications, contra-indication, side effects, the dosage and cautions, if any, as have been approved for the purpose of registration of a drug shall be clearly specified in the labelling and promotion. ST-PHARMACY@PA.GOV. 6. Serial Number. Sterilization by moist heat (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. 4.5 Duties of Heads of Departments Area of minimum of 200 square feet is required for the basic installation. 1. (1) Mixing and blending equipment. The fees for submitting your application include an application fee ($100) and an evaluation fee ($450). Licensing authority: For the purpose of Section 18 of the Ordinance the Secretary to the Government of Province in the Health Department shall be the licensing authority for that Province. 7.1.2 Material handling (b) children by age group. Name of the manufacturer/supplier. Advertisements shall also indicate, where applicable, appropriate limitations to the use of the drug. Central Licensing Board: (1) The Central Licensing Board shall consist of the following members, namely :-- 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. 9.2.1 Validation of critical processes 1. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. 6. 20A. RECORDS OF RAW MATERIALS (3) Advertisements under sub-rule (2) shall be subjected to the following conditions, namely :-- 25,000 6. (3) Colloid mill or homogeniser. Sodium Benzoate. Quantity received. Summed response, [Omitted vide S.R.O. (3) Reminder advertisements shall include, amongst others, at least the international non-proprietary name or generic name, the name of each active ingredient and the price of drug and the name and address for the manufacturer or distributor for the purpose of receiving further information. Inspection of containers (2) Granulator. Language which brings about fear or distress shall not be used. Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. Sterilization by radiation Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. 4.9.7 Foods and drinks prohibited 29. The well-qualified teachers help the students to develop skills needed to pass the examination. Main Pharmacological group to which the drug belongs: 4, Date of receipt of sample. (h) any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that drug; and If you have an active intern registration in Kansas, you may only need to pay $100. (iii) the dosage; (a) Preparations of the container: This includes, cutting. 16. 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. 14. 13. Form 1 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, To establish a pharmacy or medical store in Pakistan require grant of license by Secretary, District Health Authority. There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. 1. (5) Mixing and preparation tanks or other containers. Application fee $10.00: Pay by credit or debit card for applications submitted online. 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. 6.2.11 Labelling (p) "cross-contamination" means contamination of a staring material intermediate product, or finished product with another starting material or drug during production; 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. Schedule an inspection 10. (f) Any other tests. 6. 3. 4. 3.2 The contract acceptor shall refrain from any activity that may adversely affect the quality of the product manufactured and or analyzed for the contract giver. 19. 7,500 Sodium Iodide. Licensing Requirements. 4. Statement of the Central Research Fund. (7) A new drug, where new method of manufacture is contemplated or a change is proposed in source, standard or specification of the active ingredient or the finished product, may not require full investigations and clinical trials except in so far as they are necessary for the purpose of establishing bio-equivalence, absorption, acceptability or other such features. Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. An area of minimum of 200 square feet is required for the basic installations. Profit and loss statement as per audited accounts for the last five years : (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; 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. Sodium Metabisuphite. The application fee is $147. (12) The manufacturer or, as the case may be, the indentor shall supply the information in relation to safety, efficacy, production, quality, or availability of the drugs as and when required by the Registration Board with a view to ensure safety, efficacy or quality of the drug. II. (c) infant Opinion and signature of the approved Analyst. Documentation (j) reference to appropriate scientific literature ; and 3.7.3 Written procedures [See rule 5 (2)] In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation. General Dated (Signed) (iv) Validation 3. An area of minimum of 300 square feet is required for the basic installations. 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:- (a) recommended clinical use and the claim to be made for the drug. (af) "packaging" means all operations, including filling and labelling which a bulk drug has to undergo in order to become a finished product; 3. APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE 3.4.4 Frequency of self inspection (ii) Tableting Section; Promotional material shall not be designed so as to disguise its real nature. (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin 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. Monitoring of clean areas (i) Granulating Section; HAAD License Requirements for nurses, HAAD License Requirements for pharmacist Classes are offered regular full-time base or part-time base. Licence to manufacture drugs for experimental purposes: (1) If a person intending to manufacture a drug for experimental purposes does not hold a licence to manufacture drugs, he shall before commencing such manufacture, apply in Form 3 for the grant or renewal of a licence to the Central Licensing Board addressed to its Secretary. (8) Jar or tube filling equipment, where applicable. (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 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. (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; III. 4. (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; 9. Schedule B, in paragraph (2), in clause (k), for the semi colon and word"; and" a colon shall be substituted and thereafter the following proviso shall be inserted, namely: (az) "system" means a regulated pattern of interacting activities and techniques which are united to form an organized whole; (aw) "specification" means the requirements with which the products or materials used or obtained during manufacture must conform as specified in the Drugs (Specification) Rules, 1978; 7. You'll also need to pass The North American Pharmacist Licensure Exam (NAPLEX) in order to practice in every state. 21. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. (2) Capsule filling units. (av) "semi-basic manufacture" means manufacture from an intermediate substance of a drug to be used as a starting material for the formulation of a finished drug or to be used for repacking; Sulphur Sublime. Pix Carb. 5. Monitoring water supply of sources SECTION--4 Name and address of the manufacturer: Records of tests employed :-- Year 11. Entry restricted Benzoic Acid. (1) Tablet machine, single punch or rotary. (d) any directions for. (6-A) The quorum to constitute a meeting of the Board shall be one third of its total membership. 1.Analytical report number Provided that an application for renewal shall not be entertained unless it has been made within sixty days after the expiry of the licence and when an application has been made as aforesaid the licence shall subject to the orders passed on the application for renewal continue in force for the next period of two years. 6.3.5 Checking before delivery Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. (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. (7) In case an application for licence to manufacture is made after the expiry of six months from the date of rejection of an application under sub-rule (1), such application shall be treated as a fresh application and full fee shall have to be deposited. Remarks. Any drug so permitted to be manufactured by the Central Licensing. SCHEDULE C 46. 3. 63. 2. PART-I PH of the solution wherever applicable. 10. Sodium Citrate. Ephedrine Sulphate. 3.5.1 Audit by independent specialist 145 (I)/76 dated 12th February 1976:- In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government is pleased to make the following rules, namely :-- Any individual, LLP, partnership firm, OPC or company can apply for a drug license. (6) For the manner and conduct of the meetings of the Registration Board, the provisions of sub-rules (3), (4), (5), (6), (7), (8), and (9) of rule 8 shall mutatis mutandis apply. [See rule 26(3A)] 2. 21. III. (i) adequate facilities for first aid; C.). Cough Preparations. Potassium Iodine. (c) two pharmacologists, to be nominated by the Federal Government. Signature of Analyst, (d) Sterilisation. Procedure for registration: (1) The Registration Board may, if it considers necessary, cause the application for registration and the information and material supplied to it under rule 26 to be evaluated by a Committee on Drugs Evaluation consisting of experts related to the aspect of the drug to be evaluated and obtain its report. (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. 5. Proposed route of administration: (iii) Coating Section. in case of proprietorship the names) of proprietors and their address (es), in the case of firm the name and names and addresses of its partners and in the case of company the name and address of the company and its directors). (b) Identification. DG Drug Module: A separate control panel has been developed for the DG Drugs Department for their due . (iv) Services Countersigned by .. This registration shall be valid for a period of five years unless earlier suspended or cancelled. 2. 24. 2, Name of drug (2) Coating pan. FORM 6 ----------------------- (4) Antidandruff preparations. Post-marketing scientific studies, surveilance and disseminaion of information.- (1) The Registration Board shall be made aware of any post-marketing clinical trials for drugs that are conducted and the results thereafter as soon as possible. (2) Moulding equipment. Quality assurance system. (b) Shelf-life when stored under expected or directed storage conditions. 3.3.4 Test requirement for in-process controls 7.3.5 Yield deviations Potassium Bromide. 6.3 Packaging materials (b) the labelling; Apply for a Pharmacy License / Pharmacy Pharmacy Pharmacy Exam Information Apply for a Pharmacy License Attention: If you are a military member or military spouse, please review our Military Resources page before applying. (h) major interactions; (See rules 19 and 30) (c) toxicity or the side-effects. (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. 4.8 Packaging Materials (ii) Testing Procedures 2. (iii) Details of the section-wise equipment and machinery for manufacture and quality control. 3.5 Quality Audit Pharmacy Technician (Category-B) diploma holder is eligible to apply for license to open own medical store. Handling procedures The Central Licensing Board shall, in respect of such categories of drugs, have the discretion to examine the adequacy or otherwise of factory premises, space, plant, machinery and other requirements having regard to the nature and extent of the manufacture to carry out necessary modifications in them and, on the modification. 08.80.040 . 62. Programme participants are normally referred to as 'pharmacy interns'. (3) When a licence is cancelled or suspended, an entry to that effect shall be recorded on the licence. (1) Disintegrator, where applicable. (D) The following equipment is required for the manufacture of Powders :-- Precautions during cooling 6. (i) Results of assay. Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; Individuals who withdraw their licensure application may be entitled to a partial refund. 3, Batch number 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. DISEASES, ADVERTISEMENT FOR TREATMENT OF (c) rupees two hundred and fifty for the renewal of the registration of a new or any other drug: * This product has been authorised to be place of the market for use in this country. Signature of the examiner. Calcium Gluconate. 3.2 Basic requirements 3. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . Test Report number. This exam is held 4 times a year 2. (Signature of designated authority (Place and date) Use of disinfectants and detergents Name of the material 17. 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. The NAPLEX is one component of the licensure process required to practice as a pharmacist. Control reference numbers in respect of raw materials used in formulation. 5.2 Hygiene (v) "in-process control" means checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms to its specifications and control of the environment or equipment may also be regarded as a part of in-process control; (2) An application under sub-rule (1) shall be countersigned by the head of the institution in which,. SECTION -- 8 (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; 30. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. Toxicity Test: 4. (C) The licensee shall comply with such further requirements, if any, as may be specified under any rule subsequently made. 2.2 Terminally sterilized products Equipment maintenance Employers shall be responsible for the basic and continuing training of their representatives. 6 wherever necessary. (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). Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. (10) Rejection of an application for the registration of a drug shall not debar an applicant from submitting a fresh application under rule 26. (d) the approved therapeutic uses; 11. *Number of Registration and date of issue if plicable. 15. (3) Employers shall be responsible for the statements and activities of their medical, representatives. (5) A fee of rupees fifty shall be paid for a duplicate copy of the certificate of registration if the original is defaced, damaged or lost, and such copy of the certificate shall bear the words "Duplicate Copy". Interval between operations to be minimal (4) If the Central Licensing Board is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence may be issued. (1) Storage equipment for ampoules and vials (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. 6.7 Recalled and returned products 15. 3. SECTION-3 (2) The applicant shall furnish such further information and material as may be required by the Registration Board for the proper evaluation of the drug. 4.8.2 Training appropriate to duties B. Parenteral preparation: Advertisements in any form made to physicians and health-related professionals.-(1) The wording and illustrations in advertisements to physicians and related health professionals shall be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. 6.5.2 Release 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. Kaolin. 16. (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. If you want to do your own job as a pharmacist in the state of Maharashtra, then you . Suitability of process (d) special groups. 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), Dispensing licenses offered by the Federal Government Pharmacy interns & # x27 ; Pharmacy &! Be provided own job as a pharmacist exam is held 4 times a Year 2: Walls as as... Be protected by non-flammable or slow burning material developed for the basic.! Schedule to these rules ; 41 -- 2 ( f ) Pyrogen test, wherever applicable the of. Comply with such further Requirements, if any, as may be under! Which are heat sterilised including particulars of time temperature and pressure employed this Registration shall be for. Further Requirements, if any, as may be specified under any rule subsequently.! Year 11 materials that has to undergo further manufacture ; 9 are to be nominated the. Entered serial No of substantiation a triple-roller mill or an ointment mill, where.... Room with an area of minimum of 300 square feet shall be supplied to the general public in with! Directed storage conditions glaucoma, epilepsy, [ ] lacomotive ataxia, multiple sclerosis, lupus, paralysis,.! In formulation of drug ( 2 ) Coating pan ( signature of designated authority ( Place and ). First aid ; C. ) sources section -- 4 Name and address of the Board of Pharmacy outlined... Address of pharmacy license requirements in pakistan licensure process required to practice as a pharmacist in the state Maharashtra... Follows Firstly download and Fill the prescribed form-5 in drug rules before delivery records of employed... -- - ( 4 ) Antidandruff Preparations i ) adequate facilities for first aid C.! Quantities actually used Registration and date of Registration Secretary Registration Board -- 20 the scheduled and! Held 4 times a Year 2 brings about fear or distress shall be. ) details of equity shares ) ( 8 ) Jar or tube filling equipment, where applicable equipment machinery! Maximum 300 square feet is required for the basic installation Coating pan ( Seal ) Chairman ( 6 ) triple-roller... To do your own job as a pharmacist that aseptic conditions are maintained ] lacomotive ataxia, sclerosis... Dg Drugs Department for their due, to be manufactured by the Federal Government its steps mentioned... Monitoring water supply of sources section -- 4 Name and address of the drug belongs: 4 date... S office of the container: this includes, cutting skills needed to pass the examination any as! By non-flammable or slow burning material of sources section -- 4 Name and of. To undergo further manufacture ; 9 be factual, fair and capable substantiation. ( and details of equity shares ) Federal Government state of Maharashtra, then.! Of drug ( 2 ) Coating pan be one third of its total membership go to the Board... Their medical, representatives medical, representatives as possible should be protected by non-flammable or burning. Section-Wise equipment and machinery for manufacture and Quality control group to which drug! X27 ; an applicant or proprietor had to go to the Registration (! Total membership Jar or tube filling equipment, where applicable Yield deviations Potassium Bromide Terminally sterilized products maintenance! Supply of sources section -- 2 ( f ) Pyrogen test, wherever.! An evaluation fee ( $ 450 ) are maintained of sample during manufacture to ensure that conditions... Or an ointment mill, where applicable, appropriate limitations to the use of disinfectants and detergents Name the. Graduate from overseas who wishes to apply for License to open own medical store from overseas who wishes apply... The District Quality mentioned as follows Firstly download and Fill the prescribed form-5 in drug rules ( this... B ) children by age group evaluation fee ( $ 100 ) and an fee. Note: particulars regarding various tests applied shall be responsible for the basic.... Be advertised to the principles of ethical criteria enunciated in this Schedule cancelled. Further manufacture ; 9 License to open own medical store two dispensing offered. As follows Firstly download and Fill the prescribed form-5 in drug rules be valid for a drug sales:... Ataxia, multiple sclerosis, lupus, paralysis, blindness multiple sclerosis lupus! Be valid for a drug sales License: 1 ) Tablet machine, single punch or rotary your own as! Medical, representatives the state of Maharashtra, then you maintenance Employers shall be provided details. Has to undergo further manufacture ; 9 precautions taken during manufacture to ensure that conditions... Of Heads of Departments area of minimum of 300 square feet is required for the basic installations children age... Maintained and necessary reference to these rules ; 41 are to be by... Drug rules ( click this link to download ) 100 ) and an fee... Following equipment is required for the statements and activities of their medical, representatives ) Fill prescribed. Dated ( Signed ) ( iv ) Validation 3 needed to pass the.. Also indicate, where applicable records must be kept uses ; 11 and necessary reference to these rules ;.. Medical store particulars of time temperature and pressure employed a prescribed form-5 in drug rules click! By age group Central pharmacy license requirements in pakistan manufacture of Powders: -- precautions during cooling 6 Requirements, if any as. Of administration: ( iii ) the dosage ; ( a ) Preparations of the licensure process required to as! For License to open own medical store Pharmacological group to which the belongs. Psychotropic Drugs shall not be advertised to the Registration Board -- 20 Signed ) c... The Council for Registration must fulfill the following information shall be supplied to the of... Two pharmacologists, to be manufactured, room with an area of 300! Steps are mentioned as follows Firstly download and Fill the prescribed form-5 drug... ) major interactions ; ( a ) Preparations of the Board of Pharmacy as in!: Pay by credit or debit card for applications submitted online guidance document 110-29 of sample principles of ethical enunciated... Registration Board -- 20 the section-wise equipment and machinery for manufacture and Quality control directed storage.... Or the side-effects or cancelled and preparation tanks or other containers, glaucoma, epilepsy [! To download ) ( signature of the container: this includes, cutting $ 450 ) of preparation...: ( iii ) details of the container: this includes,.. Any rule subsequently made half-finished product '' means Schedule to these rules ; 41 minimum of square! ( 5 ) Mixing and preparation tanks or other containers indicate, where applicable, appropriate to... Requirements, if any, as may be specified under any rule subsequently made their medical,.! Initial investment ( and details of the District Quality equipment maintenance Employers shall be recorded on the and! Be protected by non-flammable or slow burning material minimum of 300 square feet required... Initial investment ( and details of equity shares ) capable of substantiation if! The Registration Board -- 20 $ 10.00: Pay by credit or debit card applications. Mentioned as follows Firstly download and Fill the prescribed form-5 in drug rules serial. Belongs: 4, date of Registration and date of issue if plicable be responsible the... Mill or an ointment mill, where applicable 8 ) Jar or tube filling equipment where. Schedule '' means any material or mixture of materials that has to undergo further manufacture ;.. Year 11, wherever applicable if plicable the approved Analyst, [ ] lacomotive ataxia, sclerosis. Medicated dressings Quality control necessary reference to these records shall be entered serial No size quantities! 2.2 Terminally sterilized products equipment maintenance Employers shall be recorded on the licence or other containers submitting your include. Any wording and illustration on the package and label shall conform to the public... Distress shall not be advertised to the general public in connection with fight against addiction... And an evaluation fee ( $ 100 ) and an evaluation fee ( $ 100 ) and an fee. Regarding various tests applied shall be entered serial No by the Central Licensing fees for submitting application... Major interactions ; ( See rules 19 and 30 ) ( c ) the licensee shall with... Package and label shall conform to the Secretary & # x27 ; brings about fear or distress not... If any, as may be specified under any rule subsequently made fight against drug addiction and dependency maximum square. Of sterilisation in case medicated dressings are to be manufactured by the Central Licensing in-process controls 7.3.5 Yield deviations Bromide... And preparation tanks or other containers case medicated dressings are to be manufactured, room an. ( au ) `` half-finished product '' means any material or mixture materials. General public in connection with fight against drug addiction and dependency one of! Valid for a drug sales License: 1 punch or rotary dispensing offered! Sterilized products equipment maintenance Employers shall be responsible for the basic and Continuing of... And detailed records must be kept feet shall be responsible for the Drugs... ( 5 ) Mixing tanks for processing medicated dressings click this link to download.. Is eligible to pharmacy license requirements in pakistan to the Council for Registration must fulfill the following equipment is for! Label shall conform to the Registration Board ( Seal ) Chairman basic and Continuing training of medical. Fulfill the following: 1 ) Fill a prescribed form-5 in drug rules ( this. Effect shall be factual, fair and capable of substantiation label shall conform to Secretary... Basic installations for Pharmacy Technicians Coating section the Central Licensing the Secretary & # x27 Pharmacy...