APPLICATION FOR LlCENCE TO MANUFACTURE DRUG(S) FOR EXPERIMENTAL PURPOSES. 7.2.4 Microbiological monitory Islamabad | Karachi | Lahore | Peshawar | Quetta; Phone: 0800-03727 (Mon to Fri 08:00AM to 04:00PM) Website: www.dra.gov.pk; 1. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. (n) "consignment or delivery" means the quantity of starting material or of a drug product, made by one manufacturer and supplied one time in response to a particular request or order, a consignment may comprise one or more packages or containers and may include material belonging to more than one batch; (1) Class(es) of drugs. (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. Name of Drug(s). 3.7.7 Evaluation (g) precautions, contra-indications and warnings; (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - 3. (iii) the dosage; 7.3.9 Repair or maintenance 1. 7.1.2 Material handling Wholesale Prescription Drug Distributors License. 7. First submit an application Central Licensing Board for establishment of a pharmaceutical unit. 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. Sera. 22. [See rule 7] GOVERNMENT OF PAKISTAN (b) children by age group. prevent, the entry of air from outside. 6.1 Material, general 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:- By way of repacking Rs. General Room: and dispensing of drugs established under (b)(7) of this section must be consistent with the requirements of secs. *Number of Registration and date of issue if plicable. Sentonin. * This product has been authorised to be place of the market for use in this country. 3. [See rule 26 (3)] Records of the disposal of rejected batch and batches with-drawn from the market. (J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals DG Drug Module: A separate control panel has been developed for the DG Drugs Department for their due . (s) "formulation" means all operations involved in converting a drug into a final pharmaceutical dosage form ready for use as a finished drug including compounding, processing, formulating, filling, packing, finishing, labelling and other like processes; 4. Validation (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that drug; 7.3.6 Product pipelines (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. A pharmacy graduate from overseas who wishes to apply to the Council for registration must fulfill the following: 1. 41. [See rule 16 (bb)-7] ----------------------- 2.3 Products sterilized by filtration (6) In the absence of the Chairman, the Board may elect one of its members to preside over a meeting. APPLICATION FORM FOR REGISTRATION OF A DRUG FOR LOCAL MANUFACTURE (a) Generic/international non-proprietary name: Brights disease, cataract, glaucoma, epilepsy, [] lacomotive ataxia, multiple sclerosis, lupus, paralysis, blindness. FORM 1-A 5. Phenothlazine (B. VET. 6.5 Finished Pharmaceutical Products SCHEDULE B I-A. Quantity received. Form-7 License: This type of Drug sales license should be used for the sales of Medicines for Importers, Exporters, Indentors and Manufacturers. 20. Value of raw materials used (Active & inactive) (in Rs.) Name of the Company .Type of ownership (Partnership, Proprietorship, Public limited, Private limited, etc.) 9. Control reference numbers in respect of raw materials used. (i) if the application for renewal is made before the expiry of the validity of a certificate Rs. 2. Board shall be deemed to be an additional category of drug for the purpose of this Schedule. D. Raw materials: Proviso: Added vide S.R.O. (c) the statement of all the representations to be made for the promotion of the drug in respect of-- 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. SECTION -- 6 Ephedrine Sulphate. (10) Filling and sealing unit Batch number. 9. (1) Mixing and storage tanks. (i) Cost per retail pack of each active and non-active. Insulin. Care against fibers 4. 3.7.1 System (ii) Reasons thereof. Sterilization by ethylene oxide (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. 2.2 The contract giver shall provide the contract acceptor with all the information necessary to carry out the contracted operations correctly in accordance with the registration and any other legal requirements and the contract giver shall ensure that the contract acceptor is fully aware of any problem associated with the product, work, or tests that might pose a hazard to premises, equipment , personnel, other materials or other products. license in state where pharmacy is located and Ohio RPH license if shipping compounded medications. CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION [See rule 2 (e)] 67. Precautions during cooling Name of the manufacturer/supplier. 6.2.3 Checking of containers Each state may have different individual . 10. 4.9 Weighing Area 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:- 4 5 6 7 6.6.4 Additional testing of reprocessed materials 12,500 145 (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 :-- (h) one representative, not below the status of an officer of BPS- 19 [..], of each of the Ministries of Commerce Industries & Justice to be nominated by the Federal Government; and This exam is held 4 times a year 2. Wrapping materials (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. (j) Cost Accountant of the Ministry of Health; 2, Name of drug 1.1 Responsibility of licensee for drugs fitness for use. 8. 9. 08.80.040 . (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. Japan, USA and European Company Member countries. 6.9.1 Testing prepared reference standard 3.6.2 Person authorized Under the Pharmacy Act-1948, now all registered pharmacists in Maharashtra state pharmacy council are required to renewal of the pharmacist certificate created for themselves as per the rules made by the MSPC.. Note: The registration fee will change to $35 on September 1, 2021 and will be in effect until June 1, 2022. 3.4.5 Self inspection report 7. 4.8.2 Training appropriate to duties HTML PDF: 246-945-235: Nonresident pharmacy license. (b) the labelling; (3) Where inspection under sub-rule (2) is carried out by a Sub-Committee or panel of experts or Inspectors appointed under the said sub-rule, it shall forward to the Registration Board a detailed report of ;he result of the inspection. Mean initial temperature of each rabbit, 61. 2. 5. In order to apply for a license or submit a service request, you must first have a DELPROS user account. 10.1.3 Documentation system 6. Graduates Pharmacist Licensure by Endorsement for Non-U.S. SECTION-1 Any drug so permitted to be manufactured by the Central Licensing. (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. (6) A triple-roller mill or an ointment mill, where applicable. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided. To get a medical store license, you must complete a 2-year Pharmacy Technician B Category diploma. FORM 6 (5) Filling equipment, 5. 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. 4. Calcium Gluconate. We recommend that you send all supporting documentation to NABP at the time of submitting your application. in force for a period of five years from the date of Registration of the drug and may thereafter be renewed for periods not exceeding 5 years at a time. SECTION-I (7) Advertisement material shall be presented with courtesy and good taste and words and phrases implying urgency, uniqueness or such expressions which are absolute in character, such as "the most potent", "the most rapid", "the most efficacious", or which make exaggerated claims or to general claims, such as "effective in all cases" or "effective against all complaints" or superlatives shall be avoided. The Doctor of Pharmacy degree (often abbreviated Pharm.D. Weight of granules. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. Licence to manufacture drugs by way of repacking: (1) A licence to manufacture drugs by way of repacking is required for the repacking of such drugs, and under such conditions, as are specified in Schedule D. Such copy of the licence shall bear the words "DUPLICATE COPY". 7.4.6 Label verification The profit margin of retail pharmacies or medical stores ranges from 15 20 to 20% for each product. (d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. Name of Indenter/Manufacturer's agent/Importer (in case of imported drugs only). Filter safety CHAPTER I - PRELIMINARY Application fee for Advertisement. Sterilization 7.1.4 Yield checks (u) "half-finished product" means any material or mixture of materials that has to undergo further manufacture; The licence is subject to the conditions prescribed in rule 22 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, and such other conditions as n3ay be subsequently prescribed or Specified by the Central Licensing Board in this behalf. 10. 3. Response. 65. (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 FORM 2 10. (c) two pharmacologists, to be nominated by the Federal Government. 6.7 Recalled and returned products (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; (ii) The licence authorises the sale by way of wholesale dealing and storage for sale by the licensee of the products manufactured under this licence, subject to the conditions applicable to licences for sale. Market your pharmacy Whether the drug is registered for local manufacture or import (i) If the application for renewal if made before the expiry of period of validity of licence. Pharmacy Internship Report - Updated 2/11/20 (178.62 KB) Pharmacist Online Application Supplement Packet_- Updated 2/11/20 (146.65 KB) Pharmacy Technician Additional Employment Form -Updated 2/11/20 (16.3 KB) Pharmacy Technician Change of Employment Notification Form - Revised 2/4/2022 (108.64 KB) Pic Change Request Form - Updated 2/20/20 (75. . (2) The Registration Board may refer any case for detailed .examination to the committee of experts on the Drugs Evaluation constituted under Section 10 of the Act. (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; Batch Size, DRUGS FOR REPACKING Quality control. 2.8 Defective Equipment 6.1.2 Appropriate storage 5.1 Sanitation Pack size (s) and proposed maximum retail price with the following details:- MATERIALS 1. 10 Major Steps And Requirements To Open Your Independent Pharmacy 1. (8) In respect of new drug, records, including adequately organised and indexed files, shall be maintained containing full information regarding-- 24. Eliminate fibers (iii) Written Procedures 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor. 8. (4) A drug or any substance referred to in clause (ii) of Section 24, may be advertised through Press without reference to the Federal Government if it is merely intended to inform the public of the availability or the price of such drug or any substance referred to in clause (ii) of Section 24 subject to the condition that the Federal Government may prohibit such advertisement if, in its opinion, the public interest so requires. (6) No advertisement under this rule shall contain any direct or indirect comparison in any way with any other drug or substance or remedy for any disease for the purpose of attracting customers or with a view to discredit other such product. II. Magnesium Sulphate. 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 :-- (9) Benches for filling and sealing. Manufacture on more than one set of premises: If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. 4.7 Special Materials Drug Regulatory Authority of Pakistan. 3. Such claims shall not contain misleading, unverifiable statements, omissions likely to induce medically unjustifiable use of a drug or to give rise to under risks. [See rule (5(I)] 3. (ay) "starting material" means any substance used in the production of a pharmaceutical product but excluding packaging materials; 2. (f) the applicant shall ensure that-- (3) Employers shall be responsible for the statements and activities of their medical, representatives. 10.4.8 Standard operating procedures The following basic hygienic requirement shall be complied with (a) Generic international non-proprietory name: 10. SECTION-2 Provided that member nominated by a Provincial Government may follow the procedure as laid down for a Provincial Inspector. 3. 3.4.2 Items for self inspection The tanks or containers shall be made of either glass or such material which will not react with the liquid Toxicity Test: 1. SECTION--4 1. 3. [See rule 31 (1A) and (1B)] Place . (2) They shall come into force at once. 6.2.5 Delivery from different batches There should be no drains at all in plants and in warehouse. Name of the sample. 4.9.7 Foods and drinks prohibited Though licensing applications and processes differ from state to state, everyone will need the following: Proof of graduation from an accredited institution; 4.6 Rejected Materials Procaine Hydro-Chloride. (g) Toxicity test, wherever applicable. (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: 7.4.5 Printing operation checks In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meters is required. PharmD Program Accreditation This professional degree program leading to the Doctor of Pharmacy degree is judged to meet established qualifications and education standards through initial and subsequent periodic evaluations. Omitted vide S.R.O. 1. 7.4 Packaging operations 4.5 Sampling Opinion and signature of the approved Analyst 51. Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. Sufficient water must be available for fire-fighting. 7.2.3 Cross contamination checks By way of repacking Rs. 10.4.10 Equipment utilization record 30 Hours of Continuing Education. 2.1 Manufacturing operations (Such observations should be utilized for appropriate labelled storage conditions or warning statements). 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. 7.3.3 Defective equipment Date of commencement of manufacture and date when manufecture was completed, An area of minimum of 200 square feet is required for the basic installations. Promotional material shall not be designed so as to disguise its real nature. 20. 4, Date of receipt of sample. 6. (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. Calcium Lactate. Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case: Retailer's discount: The retailers discount shall be 15% of the maximum retail price. (1) Rolling machine. 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. 5. FORM -5(A) Air Classification system for manufacture of sterile products (3) Antiseptics and disinfectants for household use, excluding those containing hormone and antiniotics. Comparison of products shall be factual, fair and capable of substantiation. Name and address of the manufacturer Storage Areas Pharmacy licensing. B. Parenteral Preparations 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. sealing unit, (j) reference to appropriate scientific literature ; and 1362(I)/96-28.11.96). 10.4.4 Recording batch numbers [Omitted vide S.R.O. 8. 3, Batch Size, Calculated Paid investment Turnover 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. 5 whenever necessary. 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