Granulating Section: (1) Disintegrator, where applicable. 50. Nebraska Governor Pete Ricketts recently signed Executive Order No. (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. 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. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. approve the contents of such advertisement and specify conditions subject to which such advertisement shall be made: (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. 5. 8. 5000By way of semi-basic Rs. 10.1 Documents 19. 5.3 General Requirements for Production Areas The granulation, tableting and packing shall be done in this room. (b) children by age group. Name of the Sample (iii) Cost of direct labour, Maximum temperature. 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. SECTION--6 (r) "Form" means a form set forth in Schedule A; Conditions for the grant or renewal of licence to manufacture drugs by way of formulation: Before a licence to manufacture drugs by way of formulation is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are being complied with by the applicant namely :-- (5) Filling equipment, (6) Any fee deposited under sub-rule (3)shall in no case be refunded. 2. 5. 47. 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. 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. 2. [See rule 26 (3)] Manufacture of sterile preparations 3.6.3 Written procedures 1,000 per advertisement. 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. 6.3.4 Obsolete materials (ac) "master record" means a document or set of documents that serve as a basis for the batch documentation (blank batch record); 1. (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. The License can be renewed as it is valid for up to five years. (i) Reference Books Place.. Name, designation and address Description of the method of manufacture and quality control with details of the equipment. 7.4.9 Product re-introduction on packaging line 3.3.5 Test Requirement for Finished Products 3. Details of Disposal 190.00 Renewal Fee. 1.1 Location Records of readings taken to check weight variation in case of capsules, Water supply (i) enclose certificate of registration and Free Sale from any of the following countries: 4.6 Duties of Production Incharges (b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material. 48. 15, Reference to Analytical Report numbers stating whether of standard quality or otherwise. (4) The licensee shall maintain in the inspection book provided by the Central Licensing Board at the time of the issuance of the licence on which a member of the said Board or of a Provincial Quality Control Board or an Inspector shall record proceedings of each of his visits, his impressions and the defect or irregularities noticed, if any, by him and such inspection book shall be signed by him as well as the licensee or his authorised agent. 1.3 All arrangements for contract manufacture and analysis, including any proposed changes in technical or other arrangements, shall be in accordance with the registration of the drug concerned. (a) The applicant shall provide premises which shall be suitable for intended use, in size and construction and shall be located in an area free from offensive and obnoxious odours and other possible sources of contamination. 34. Duration of a licence to manufacture drugs: A licence issued under this Chapter shall, unless earlier suspended or cancelled, be inforce for a period of five years from the date of issue and may thereafter be renewed for periods of five years at a time: (4) A fee of rupees one hundred shall be paid for a duplicate copy of the licence if the original is defaced, damaged or lost. You will need to complete an Applying for eligibility to complete an Overseas Pharmacists' Assessment Programme (OSPAP) form so that we can assess your eligibility to apply for an OSPAP course. 1. 8. Requirement for Pharmacist License Must hold a pharmacy certificate from a recognized high institute, college or university. of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks. Sterilized surgical lignature and sterilized surgical suture. (m) one expert in veterinary medicine to be nominated by the Federal Government. Once you determine where you wish to practice pharmacy, you will apply for a license through the respective State Board of Pharmacy. 10.4 Batch packaging records Provided that: (viii) Light Date of compression in case of tablets/date of filling in case of capsules. (iii) Coating Section. It is certified : (g) Results of assay. Pharmacy exam: Questions will cover broadly most area of pharmacy, clinical, pharmacology, therapeutics, pharmacy calculations, over the counter medicines and patient counseling Eliminate fibers PART-I 1. Validation 3. (2) Granulator. Verification can be emailed An area of minimum of 250 square feet is required for the basic installation. (i) "biological agents" means micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not; ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF A DRUG (bb) An applicant for registration of insecticides, pesticides and household disinfectants shall, in addition to the conditions specified in Schedule B and Schedule B-l, comply with the conditions specified in Schedule B-l, A. Apply for insurance 11. 5. (ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate (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. Batch number. (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; (c) if any adverse drug reaction not otherwise included in the application for registration, is registration, is registered in any of the said countries, it shall be the responsibility of the concerned manufacturer or in case of imported drugs the indentor or manufacturer's agent in Pakistan, to be aware of such adverse action and to report to the Registration Board within thirty days of becoming so aware. 2. 2. Sulphur Sublime. (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 3.7.7 Evaluation Rs. (2). SECTION--4 Alniminium Hydroxide Gel Dried. (iii) Name of the drug(s) registered/approved. Present investment (and details of equity shares). In Pakistan a person who has following qualification will be considered as an eligible candidate for course of pharmacy technician; Matriculation with science from a recognized institute of Pakistan. (i) 6.3.2 Printed materials I.being a person resident in Pakistan, carrying on business at (full address) under the name of(and being an importer/indenter/authorised agent of ), do hereby give this warranty that the drugs here-under described as sold/indented by me/specified and contained in the bill of sale, invoice, bill of lading or other document describing the goods referred to herein do not contravene in any way the provisions of section 23 of the Drugs Act, 19.76. Building Layout And Its Pre-Approval3. (5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin Date of Registration Secretary Registration Board (Seal) Chairman. The following equipment required :- 12. STEP 4: Apply for PSV. 4.3 Bays Results and remarks, Date of commencement of manufacture and date of completion. 3.2 Services 13. A. Tablets and capsules: 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. SECTION-1 Preparation of live organisms (3) Name of the drug(s). APPLICATION FORM FOR REGISTRATION OF AN IMPORTED DRUG Potassium Bicarb. (3) If the Central Licensing Board, after' such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules have been complied with, it may issue a licence in Form 2. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory. Venereal diseases. How to get a pharmacy license in Pakistan? 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; There are two dispensing licenses offered by the Board of Pharmacy as outlined in guidance document 110-29. (ii) Others General SCHEDULE G (an) "quarantine" means status of starting or packaging materials intermediate, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection, or reprocessing; 4.4 Quarantine Air supply system 4.8 Packaging Materials (3} Granular 35. [See rule 20 (b)] (4) Water still. 6.3.5 Checking before delivery 10.1.10 Starting material re-assay Visa, Mastercard. Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : Pharmacists will have to arrange their own internship in either a hospital or community pharmacy setting. 6.11 Miscellaneous The text shall be fully legible. 3.4.1 General 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. If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules. 7.4.1 Avoiding mix-ups Procaine Hydro-Chloride. Verification of Licensure - If your pharmacy holds a current pharmacy license or ever held a pharmacy profession license, verification of licensure will be required to be submitted directly to this office by the licensing agency of any state of the United States in which you hold or ever held a license. (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. 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 :-- 10. If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. (3) Punch and dyes storages cabinet. (d) any substitution of another substance for that drug or any mixing of another substance with that drug; 10. Location and Surroundings . {4) Heater and exhaust system, where applicable. (j) One Surgeon, to be nominated by the Federal Government. Pharmacies must also be registered with the GPhC (or be a pharmacy department based in a hospital or health centre) to operate in Great Britain and to use the title 'pharmacy'.