DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (DRGD)PRODUCT OWNER Letter Head (full and complete address, email address, telephone and fax number)(Please state) Date of LOA (the existing PRH shall submit an application within 6 months from this date)Drug Control Authority,Lot 36, Jalan Universiti,46200 Petaling Jaya,Selangor, Malaysia.Dear Sir/ Madam,LETTER OF AUTHORIZATION FOR TRANSFER OF PRODUCT REGISTRATION HOLDERThe above subject matter is referred.Due to (please state) reason of the transfer,2. We, Name of registered Product Owner, the undersigned as the product owner for the said product(s)listed below:Name of Product(s)Registration Number(If number of product > 10, endorsed attachment is allowed.)hereby authorizeCompany name with business registration number and full address of the proposed new PRHto be the Product Registration Holder and to act on our behalf/ responsible for all matters pertaining to theregistration of the listed product(s) including obtaining approval for any subsequent product variation andmaintenance of the product(s) registration.3. Therefore, we hereby terminate marketing authorization of the existing Product Registration HolderCompany name with business registration number and full address of the existing PRHfor the listed product(s) effectively on date of authorization / termination.4. We shall confirm that the entire dossier of the listed product(s) includes all the data in support of theoriginal application, together with all correspondence with the Drug Control Authority (DCA)/ NationalPharmaceutical Control Bureau concerning the listed product(s), to be transferred from Company name of theexisting PRH to Company name of the proposed new PRH upon the approval from DCA.Thank you.Sincerely,*Company officer‟s signature(s)*Full name & Title/ PosititionCompany stamp**Certified byNotary Public/Commissionerfor Oathcc:Company of proposed new PRHCompany of existing PRHProduct Manufacturer(A copy of LOA shall be sent tothese companies by theProduct Owner)IMPORTANT NOTICE:1. *LOA shall be signed by Managing Director/ Director/ President/ Chief Executive Officer/General Manager who has overall responsibility for the company or organization.2. **LOA shall be certified by Notary Public of the country of origin for overseas company orMalaysia Commissioner for Oath for local company.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 118
Drug Registration Guidance Document (DRGD)16.3.7 FLOWCHART FOR THE CHANGE OF PRODUCT REGISTRATION HOLDERCompany (Existing PRH)Submit completed application to NPCB as below;1. Application Form BPFK-430.52. Borang Penyerahan Permohonan BPFK-0013. Processing Fee4. Original Supporting Documents consisting of;LOA from product owner certified by Notary Public foroverseas company or Commissioner For Oath for localcompanyResolution by Company Board of Directors of local productownerThe latest Form 24 and Form 49 of local product ownercertified by Commissioner for OathResolution by Company Board of Directors of existingPRHThe latest Form 24 and Form 49 of existing PRH certifiedby Commissioner for OathCompany/ Business Registration Certificate of proposednew PRHStatement of Acceptance As Product Registration Holder;BPFK-430.5(3) completed by proposed new PRHSecretariatReceive documentations and evaluation of applicationSatisfactoryNon-satisfactorySecretariatProcessing of evaluated application1. Satisfactory:a) Table to DCA meeting for approval2. Non-satisfactory:b) Table to DCA meeting for rejection (processing fee isNON REFUNDABLE in the event that application isbeing rejected)DCA MeetingSecretariatProcessing of DCA meeting outcome1. Notification of transfer approval to new proposed PRH andtermination notification to existing PRH for approved application;OR2. Notification of transfer rejection to existing PRH for rejectedapplicationNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 119
Page 1 and 2:
Drug Registration Guidance Document
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11:
Page 16 and 17:
Page 18 and 19:
Page 20 and 21:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69: Drug Registration Guidance Document
Page 168 and 169:
Page 170 and 171:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Appearance/organoleptic(odor, color
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
ATTACHMENT 1Drug Registration Guida
Page 222 and 223:
Page 224 and 225:
Page 226 and 227:
Page 228 and 229:
PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231:
ATTACHMENT 2Drug Registration Guida
Page 232 and 233:
Page 234 and 235:
Page 236 and 237:
APPENDIX 5:Drug Registration Guidan
Page 238 and 239:
1. GENERAL INFORMATIONSDrug Registr
Page 240 and 241:
Page 242 and 243:
Page 244 and 245:
Page 246 and 247:
Page 248 and 249:
Page 250 and 251:
Page 252 and 253:
Page 254 and 255:
Page 256 and 257:
Page 258 and 259:
Page 260 and 261:
Page 262 and 263:
Page 264 and 265:
Page 266 and 267:
Page 268 and 269:
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Route of AdministrationTAMC(CFU/g o
Page 276 and 277:
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
e) Example of label approved by the
Page 284 and 285:
Page 286 and 287:
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
Page 294 and 295:
Page 296 and 297:
Page 298 and 299:
Page 300 and 301:
Page 302 and 303:
Page 304 and 305:
Page 306 and 307:
Page 308 and 309:
Page 310 and 311:
Page 312 and 313:
Page 314 and 315:
Page 316 and 317:
Page 318 and 319:
Page 320 and 321:
Page 322 and 323:
Page 324 and 325:
Page 326 and 327:
Page 328 and 329:
Page 330 and 331:
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
Page 338 and 339:
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 374 and 375:
Page 376 and 377:
Page 378 and 379:
Page 380 and 381:
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486 and 487:
Page 488 and 489:
Page 490 and 491:
Page 492 and 493:
Page 494 and 495:
Page 496 and 497:
Page 498 and 499:
Page 500:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Create successful ePaper yourself

Delete template?

Save as template?